BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT

    MDR report key: 7116557 · Received December 13, 2017

    Report

    Report Number
    MW5073956
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    December 5, 2017
    Report Date
    December 12, 2017
    Manufacturer
    ABBOTT
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS POST STENT PLACEMENT TO THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ATTEMPTED TO PLACE THE PERCLOSE VASCULAR DEVICE TO CLOSE THE ARTERIAL PUNCTURE TO THE RIGHT FEMORAL ARTERY. DURING DEPLOYMENT OF THE DEVICE, THE DEVICE MALFUNCTIONED RESULTING IN NON-CLOSURE OF THE FEMORAL ARTERY AND THE INABILITY TO REMOVE THE EXISTING DEVICE FROM THE ARTERY WITHOUT CAUSING INJURY TO THE ARTERY. A VASCULAR SURGEON WAS CONSULTED. HE TOOK THE PATIENT URGENTLY TO THE OPERATING ROOM FOR CUT DOWN AND REMOVED OF THE PERCLOSE DEVICE. POSSIBLE DAMAGE TO THE RIGHT FEMORAL ARTERY NOTED. DIAGNOSIS OR REASON FOR USE: ARTERY CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891749 ABBOTT PERCLOSE PROGLIDE 6F MQB ABBOTT WPL2102100-01 7102541

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization