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Adverse Event Report

COOK VASCULAR, INC. VITAL-POT VASCULAR ACCESS SYSTEM   back to search results
Model Number 7012
Event Date 08/14/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Pt had puffiness around the implant site and they experienced problems obtaining blood return. Angiography showed the catheter had separated from the port and a segment of the catheter had migrated to the right atrium.

 
Manufacturer Narrative

H6 code 100: both ends of catheter had been cut by user. Catheter most likely not advanced over locking bead on port connector tube. History: the subject port was for evaluation and analysis. The catheter had separated from the port housing. Analysis: the port was returned in three separate components: the catheter, the catheter lock assembly, and the port housing. The catheter measured 9. 8 inches long, one end of which exhibited an approximately square instrument cut, and the other end of which exhibited an angled instrument cut. The location of the insertion depth markings indicated that although the port-catheter assembly was supplied as a pre-attached model, the physician had implanted it as a detached model. Examination of the catheter revealed a circumferential wear mark on the inner diameter near the angled end. There was no other evidence of a connection to the port housing. Conclusion: the most likely cause of the catheter separation from the port housing is that during connection to the housing, the catheter was not advanced over the locking bead of the connector tube, resulting in subsequent detachment of the catheter.

 
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Brand NameVITAL-POT
Type of DeviceVASCULAR ACCESS SYSTEM
Baseline Brand NameVITAL-PORT
Baseline Generic NameVASCULAR ACCESS SYSTEM
Baseline Catalogue NumberIP-7012
Baseline Model Number7012
Other Baseline ID NumberIPS-7012
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
leechburg PA 15656
Manufacturer (Section D)
COOK VASCULAR, INC.
p o box 529
leechburg PA 15656
Manufacturer (Section G)
COOK VASCULAR INC.
1186 montgomery lane
vandergrift PA 15690
Manufacturer Contact
richard shirey
p.o. box 529
route 66 river road
leechburg , PA 15656
(724) 845 -8621 ext 266
Device Event Key118953
MDR Report Key121440
Event Key114164
Report Number2522007-1997-00018
Device Sequence Number1
Product CodeLJT
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 08/26/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/01/1999
Device MODEL Number7012
Device Catalogue NumberIPS-7012
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/15/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/26/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/1996
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 January 30, 2009

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