BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CHEST PORT

    MDR report key: 536855 · Received June 7, 2004

    Report

    Report Number
    MW1032304
    Event Type
    Injury
    Date Received
    June 7, 2004
    Date of Event
    May 14, 2004
    Report Date
    June 4, 2004
    Manufacturer
    COOK, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/09/04: A REVIEW OF THE INFO RECEIVED REVEALED THIS DEVICE WAS NOT MANUFACTURED BY COOK. HOWEVER, THIS DEVICE WAS FOUND TO BE MANUFACTURED BY COOK VASCULAR CORPORATION. MFR HAS FORWARDED THIS INFO ON TO THE MANUFACTURER FOR THEIR FOLLOW-UP.

    Description of Event or Problem · 1

    CHEST PORT DISCONNECTED FROM CATHETER AT POINT OF CONNECTION. CATHETER WAS SUCCESSFULLY RETRIEVED UNDER FLUOROSCOPY.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/19/04: UPON LEARNING OF THIS INCIDENT THROUGH THE FDA REQUEST FOR MORE INFO, COOK VASCULAR INCORPORATED CONTACTED THE USER FACILITY AND REQUESTED THAT THE DEVICE BE RETURNED FOR EVALUATION. THE DEVICE WAS RECEIVED IN 2004 AND EVALUATED BY THE ENGINEERING DEPT. SINCE 1992, THERE HAS BEEN AN AVERAGE OF TWO EVENTS PER YEAR FOR THIS TYPE OF EVENT, WHICH IS CONSIDERED A CATHETER DISCONNECTION FROM THE PORT, OVER ALL VITAL-PORT MODELS. FOR THE 6113-MPIS MODEL SPECIFICALLY, THERE HAVE BEEN TWO TOTAL EVENTS OF THIS NATURE SINCE 1992, INCLUDING THE EVENT IN QUESTION. BASED NO PAST HISTORY, MFR FEELS THAT THIS TYPE OF EVENT IS OCCURRING AT AN EQUAL OR LESSER RATE THAN IS EXPECTED. IN REGARD TO THE SEVERITY OF THIS OCCURRENCE AS WELL AS PAST OCCURRENCES, NONE OF THE PAST REPORTED EVENTS HAVE BEEN LIFE THREATENING, INCLUDING THE EVENT IN QUESTION. THEREFORE, MFR FEELS THAT THIS EVENT FALLS IN LINE WITH BOTH THE EXPECTED AND OBSERVED SEVERITY. ANALYSIS: THE PORT HOUSING WAS RETURNED TOGETHER WITH THE CATHETER LOCK AND THE CATHETER. THE CATHETER CONNECTOR TUBE IN THE PORT HOUSING, THE CATHETER LOCK, AND THE CATHETER WERE DIMENSIONALLY CHARACTERIZED AND THEY WERE FOUND TO BE OF THE CORRECT SIZE. HOWEVER, EXAMINATION OF THE ENDS OF THE CATHETER FAILED TO REVEAL CIRCUMFERENTIAL MARKS WHICH ARE TYPICALLY CREATED AS THE CATHETER IS SQUEEZED BETWEEN THE LOCKING BEAD IN THE CONNECTOR TUBE AND THE CATHETER LOCK, DURING CONNECTING OF THE CATHETER TO THE PORT HOUSING. INSPECTION OF THE SUTURE HOLES IN THE PORT HOUSING FAILED TO REVEAL PUNCTURES IN THE SILICONE PLUGS IN THE HOLES WHICH WOULD INDICATE THAT THE HOUSING WAS SUTURED DOWN ONTO THE PT. CONCLUSION: THE CATHETER HAD NOT BEEN ADVANCED OVER AND BEYOND THE LOCKING BEAD IN THE CONNECTOR TUBE PRIOR TO APPLYING THE CATHETER LOCK. THIS INADEQUATE CONNECTION BETWEEN THE CATHETER AND THE HOUSING, AGGRAVATED BY THE HOUSING NOT BEING SUTURED DOWN ONTO THE PT, APPEARS TO BE THE CAUSE OF THE PREMATURE CATHETER DETACHMENT FROM THE HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CHEST PORT CHEST PORT LJT COOK, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention