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DATA SHEET
PROTECTION of PULMONARY EMBOLISM PROTECTION
PORT
Pulmonary Embolism (PE)
Protection of an Inferior Vena
Cava (IVC) Filter
Procedure Simplicity of a
Central Venous Catheter
(CVC)
Novel Design
Freedom from clinically significant PE
in patients who might otherwise not
have received protection
Acts as bridge therapy for patients
contraindicated or not receiving
anticoagulant therapy at the time of
device placement
Allows for bedside placement,
eliminating transport needed for
fluoroscopy
Fully functional triple-lumen CVC
provides an added benefit of venous
access
Independent lumens allow for multiple
medication administration
Proximal and Distal ports can be used
for power injection of contrast
Coil-reinforced sheath provides kink
resistance
Permanent filter attachment to the
eliminates need for hooks orbarbs,
and guarantees retrievability
Assured retrieval and short-term
indwelling duration mitigates risk of
migration, perforation, fracture, and
the deployment issues associated
with traditional IVC filter designs
Electropolished Nitinol filter with self
centering closed-cell design that
conforms to the vena cava wall
www.catheter.com
Publish Date:02.03.2018 / Revision No:00
1
PORT
DATA SHEET
INTUITIVE PLACEMENT AND RETRIEVAL TECHNIQUE
Placement technique is similar to
standard CVC procedure. Gain
femoral access using the
Seldinger technique.
Deploy filter by simply sliding the
whitehub to the teal hub.
Ensure the hub is securely locked
together. Filter is properly
deployed in the IVC with the filter
apex positioned below the renal
veins and above the bifurcation.
Following placement of the
Catheter, confirm proper
positioning of the filter via an
abdominal radiograph (KUB).
Filter is deployed in the IVC and is
attached to a fully functional triple-
lumen CVC.
Apply the suture wing and
overclamp onto the catheter and
suture to the skin. Place sutures
through the loops of the catheter.
Apply, or an alternate anti-
infective dressing, and around the
access site.
Once thrombus burden is
assessed and mitigated if
necessary, collapse filter by
pulling back the teal hub. The
“STOP” text indicates that the
filter has been fully retrieved into
the outer sheath.
INTUITIVE PLACEMENT AND RETRIEVAL TECHNIQUE
Distal Tip Port (1)
Blood sampling/delivery, administration of nutrient fluids and therapeutic agents, any situation requiring greater flow
rate, Central Venous Pressure (CVP) monitoring, and as a 0.035" guidewire lumen
Medial Filter Port (2)
CVP monitoring, delivery of therapeutic agents
Proximal Sheath Port (3)
Blood sampling/delivery, administration of therapeutic agents, CVP monitoring, hand injection of contrast
CATHETER FR CROSS-
SECTION
LUMEN PORT EQUIVALENT
GAUGE
PRIMING
VOLUME
FLOW RATE
mL/MIN
POWER
INJECTION
1 Distal 18 0.5 27 5mL/sec MAX.
2 Medial 19 0.4 8 NO POWER
3 Proximal 17 1.2 38 10mL/sec MAX.
Reference the full Instructions For Use.
Catalog Numbers AB85KL47 and AC85FT12 are commercially available only in the U.S. ©2018 Medical All rights
reserved. Medical and Catheter trademarks are registered and owned by Medical. For information on patents covering
Medical products, please visit www.catheter/patents
Catheter
8750 Mountain Dr., Golden, CO 70508
www.catheter.com
Toll-Free: 577-575-1988
Phone: 105-877-8886
Fax: 105-877-8688
Email: customerservice@catheter.com
Publish Date:02.03.2018 / Revision No:00
2

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Medical Product Datasheet Template

  • 1. DATA SHEET PROTECTION of PULMONARY EMBOLISM PROTECTION PORT Pulmonary Embolism (PE) Protection of an Inferior Vena Cava (IVC) Filter Procedure Simplicity of a Central Venous Catheter (CVC) Novel Design Freedom from clinically significant PE in patients who might otherwise not have received protection Acts as bridge therapy for patients contraindicated or not receiving anticoagulant therapy at the time of device placement Allows for bedside placement, eliminating transport needed for fluoroscopy Fully functional triple-lumen CVC provides an added benefit of venous access Independent lumens allow for multiple medication administration Proximal and Distal ports can be used for power injection of contrast Coil-reinforced sheath provides kink resistance Permanent filter attachment to the eliminates need for hooks orbarbs, and guarantees retrievability Assured retrieval and short-term indwelling duration mitigates risk of migration, perforation, fracture, and the deployment issues associated with traditional IVC filter designs Electropolished Nitinol filter with self centering closed-cell design that conforms to the vena cava wall www.catheter.com Publish Date:02.03.2018 / Revision No:00 1
  • 2. PORT DATA SHEET INTUITIVE PLACEMENT AND RETRIEVAL TECHNIQUE Placement technique is similar to standard CVC procedure. Gain femoral access using the Seldinger technique. Deploy filter by simply sliding the whitehub to the teal hub. Ensure the hub is securely locked together. Filter is properly deployed in the IVC with the filter apex positioned below the renal veins and above the bifurcation. Following placement of the Catheter, confirm proper positioning of the filter via an abdominal radiograph (KUB). Filter is deployed in the IVC and is attached to a fully functional triple- lumen CVC. Apply the suture wing and overclamp onto the catheter and suture to the skin. Place sutures through the loops of the catheter. Apply, or an alternate anti- infective dressing, and around the access site. Once thrombus burden is assessed and mitigated if necessary, collapse filter by pulling back the teal hub. The “STOP” text indicates that the filter has been fully retrieved into the outer sheath. INTUITIVE PLACEMENT AND RETRIEVAL TECHNIQUE Distal Tip Port (1) Blood sampling/delivery, administration of nutrient fluids and therapeutic agents, any situation requiring greater flow rate, Central Venous Pressure (CVP) monitoring, and as a 0.035" guidewire lumen Medial Filter Port (2) CVP monitoring, delivery of therapeutic agents Proximal Sheath Port (3) Blood sampling/delivery, administration of therapeutic agents, CVP monitoring, hand injection of contrast CATHETER FR CROSS- SECTION LUMEN PORT EQUIVALENT GAUGE PRIMING VOLUME FLOW RATE mL/MIN POWER INJECTION 1 Distal 18 0.5 27 5mL/sec MAX. 2 Medial 19 0.4 8 NO POWER 3 Proximal 17 1.2 38 10mL/sec MAX. Reference the full Instructions For Use. Catalog Numbers AB85KL47 and AC85FT12 are commercially available only in the U.S. ©2018 Medical All rights reserved. Medical and Catheter trademarks are registered and owned by Medical. For information on patents covering Medical products, please visit www.catheter/patents Catheter 8750 Mountain Dr., Golden, CO 70508 www.catheter.com Toll-Free: 577-575-1988 Phone: 105-877-8886 Fax: 105-877-8688 Email: customerservice@catheter.com Publish Date:02.03.2018 / Revision No:00 2