BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASOSEAL ELITE

    MDR report key: 532332 · Received June 2, 2004

    Report

    Report Number
    532332
    Event Type
    Other
    Date Received
    June 2, 2004
    Date of Event
    May 17, 2004
    Report Date
    May 25, 2004
    Manufacturer
    DATASCOPE CORPORATION, COLLAGEN PRODUCTS DIV.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CEREBRAL ANGIOGRAM IN THE ANGIO SUITE, THE VASOSEAL CLOSURE DEVICE WAS USED. WHILE DEPLOYING THE VASOSEAL CLOSURE DEVICE, THE RETAINING WIRE ON THE GUIDE CATH BROKE OFF. ALL PARTS WERE REMOVED AND PRESSURE APPLIED. HEMOSTASIS WAS ACHIEVED AND PT LEFT THE SUITE WITH NO IMMEDIATE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOSEAL ELITE USED TO CLOSE ENTRY SITE INTO VESSEL MGB DATASCOPE CORPORATION, COLLAGEN PRODUCTS DIV. * 03014872

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other CARDIAC DRUGS.