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Adverse Event Report

COOK VASCULAR, INC. VITAL-PORT VASCULAR ACCESS SYSTEM   back to search results
Model Number 5116W
Event Date 03/07/2001
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

"the implanted catheter disconnected. The implantation of the port system was without any difficulties. Then there had to be made a correction of the position of the port system and during control the disconnection catheter was found which then had to be retrieved. ".

 
Manufacturer Narrative

Analysis: the port was returned with a catheter segment, which extended 5. 7 cm from the base of the port housing, and a fractured-off catheter segment measuring 35. 2 cm long. The fracture surface was somewhat elliptical, and was smooth and shiny for about one-third of the circumference. However, it was observed that the silicone-filled suture holes had not been punctured, indicating that the port housing may not have been sutured to the body, and thus permitting unrestrained displacement of the port housing. Conclusion: the most likely cause of the catheter fracture was that the catheter was repeatedly flexed about the point of fracture. Cracking initiated and propagated through one-third of the area when the catheter completely fractured. Prior to complete fracture, abrasion of the fractured surfaces caused them to become smooth. Catheter fracture is listed as one of the potential complications on the vital-port suggested instructions for use (package insert).

 
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Brand NameVITAL-PORT
Type of DeviceVASCULAR ACCESS SYSTEM
Baseline Brand NameVITAL-PORT
Baseline Generic NameVASCULAR ACCESS SYSTEM
Baseline Catalogue NumberIP-5116W
Baseline Model Number5116W
Other Baseline ID NumberIPS-5116W
Baseline Device FamilyVITAL-PORT
Baseline Device 510(K) NumberK895030
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Date First Marketed04/17/1990
Manufacturer (Section F)
COOK VASCULAR, INC.
p.o. box 529
rte 66 river rd.
leechburg PA 15656
Manufacturer (Section D)
COOK VASCULAR, INC.
p.o. box 529
rte 66 river rd.
leechburg PA 15656
Manufacturer Contact
thomas kardos
po box 529
rte 66 river rd
leechburg , PA 15656
(724) 845 -8621
Device Event Key318690
MDR Report Key329322
Event Key309913
Report Number2522007-2001-00005
Device Sequence Number1
Product CodeLJT
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/29/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/01/2003
Device MODEL Number5116W
Device Catalogue NumberIPS-5116W-MPIS-NT
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/29/2001
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2000
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on December 31, 2008

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