BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGAGE INTRODUCER

    MDR report key: 2024195 · Received March 3, 2011

    Report

    Report Number
    2024195
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    September 13, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELDERLY FEMALE WITH DIABETES, CORONARY ARTERY DISEASE, VALVULAR HEART DISEASE, PERIPHERAL VASCULAR DISEASE, AND COMPLAINTS OF CLAUDICATION, WAS REFERRED FOR AN ELECTIVE CARDIAC CATHETERIZATION INTERVENTION. A 6 FRENCH, 65 CM DESTINATION SHEATH WAS INSERTED AND EXCHANGED FOR 7 FRENCH STANDARD SHEATH. LOT NUMBERS ARE NOT TRACKED ON THESE ITEMS AS THEY ARE A MEANS TO ACCESS THE VESSEL AND NOT INTENDED TO BE IMPLANTED. THE SHEATH WAS PULLED 6 HOURS LATER. THE PATIENT HAD AN EXTREMELY CALCIFIED VESSEL CAUSING RESISTANCE WHEN REMOVING. THE SHEATH WAS DIFFICULT TO REMOVE AND ON CLOSER EXAMINATION, IT APPEARED TO BE STRETCHED WITH COMPRESSED AREAS, AND SEEMED FRAYED AT THE END. THE PATIENT DEVELOPED A LARGE HEMATOMA. A CT ANGIOGRAM SHOWED A POTENTIAL PSEUDOANEURYSM AND SURGICAL TREATMENT WAS RECOMMENDED. PATIENT WAS NOTED TO HAVE SIGNIFICANT PLAQUE IN THE COMMON FEMORAL ARTERY, BUT RATHER THAN FINDING A PSEUDOANERYSM, AN 8.2 CM PIECE OF RETAINED PLASTIC FROM THE ORIGINAL SHEATH WAS REMOVED FROM THE GROIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENGAGE INTRODUCER INTRODUCER, CATHETER DYB ST. JUDE MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR NO OTHER THERAPIES