BEUDAMED
    FDA Adverse Event Injury Summary report: N

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    MDR report key: 5001531 · Received August 7, 2015

    Report

    Report Number
    MW5055368
    Event Type
    Injury
    Date Received
    August 7, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 31, 2015
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN (B)(6) F WITH PMH OF HYPERLIPIDEMIA & CAD. OUTPATIENT WAS SCHEDULED FOR A PCI PROCEDURE WHICH REQUIRED THE SUPPORT OF THE IMPELLA DEVICE. PROCEDURE WAS COMPLETED & IMPELLA WAS REMOVED. THE CLOSURE DEVICE COMPANY ABBOTT VASCULAR PERCLOSE WAS USED AND FAILED TO PREVENT BLOOD LOSS AT SITE. EVENT REQUIRED ADDITIONAL SURGICAL PROCEDURE TO LEFT FEMORAL ARTERY TO MAINTAIN HEMODYNAMIC STATUS AND MINIMIZE HEMATOMA FORMATION. PATIENT REQUIRED IN-PATIENT MONITORING AND ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521274 PERCLOSE PERCLOSE MGB ABBOTT VASCULAR 17170516/1050529K

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention