BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA BALLOON CATHETER

    MDR report key: 34640 · Received July 25, 1996

    Report

    Report Number
    MW1009572
    Event Type
    Injury
    Date Received
    July 25, 1996
    Date of Event
    July 9, 1996
    Report Date
    July 17, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER DEPLOYMENT OF STENTS IN LAD, PTCA BALLOON INSERTED TO INFLATE DIAGONAL. THE STENTS PLACED IN LAD CROSSED OSTIUM OF DIAGONAL BRANCH AND WIRE AND BALLOON PASSED AREA SUCCESSFULLY. AFTER TWO INFLATIONS, BALLOON "WINGED" AND UPON RETRACTION UNABLE TO PASS BALLOON BACK THRU STENT THUS UNABLE TO REMOVE BALLOON. PT SENT TO SURGERY FOR BALLOON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBRA BALLOON CATHETER PTCA BALLOON CATHETER LOX SCIMED LIFE SYSTEMS, INC. 439329

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R