BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHECK-FLO PERFORMER INTRODUCER

    MDR report key: 1141863 · Received August 27, 2008

    Report

    Report Number
    MW5008125
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 27, 2008
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    "WAS PLACING A UP AND OVER BALKIN CONTRALATERAL CHECK-FLO PERFORMER IN RIGHT FEMORAL ARTERY FOR TREATMENT OF A DISTAL LEFT SCA STENOSIS. LESION WIRED WITH A WHOLEY .035 WIRE, PREDILUTED WITH AN ANGIOSCUFT 5X20 PTA BALLOON CATHETER FOLLOWED BY 5X10 CORDIS POWERFLEX BALLOON. ATTEMPTED TO PLACE VIABAHN 6X15 7 FRENCH GRAFT STENT. UNABLE TO PASS STENT, A STIFF AMPLATZ WIRE WAS PLACED AFTER EXCHANGING WHOLEY WIRE. A NEW 6X15 7FRENCH VIABAHN STENT WAS PLACED AND DEPLOYED. UPON STENT CATHETER REMOVAL, PERFORMER INTRODUCER SHEATH SEPARATED AT VALVE AND SHEATH. SHEATH UNABLE TO BE RETRIEVED AND REQUIRED CUT DOWN SURGERY TO REMOVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHECK-FLO PERFORMER INTRODUCER BALKIN UP AND OVER CONTRALATERAL DYB COOK INCORPORATED RCFM703540RBBLKN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention