BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR PERCLOSE DEVICE

    MDR report key: 6485644 · Received April 10, 2017

    Report

    Report Number
    MW5069042
    Event Type
    Injury
    Date Received
    April 10, 2017
    Date of Event
    March 28, 2017
    Report Date
    April 10, 2017
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD 5 FRENCH SHEATH IN HER LEFT GROIN, LEFT HEART CATH DONE, NO IV GRAM, PERCLOSE DEVICE DEPLOYED IN PT'S LEFT GROIN BY MD, UNABLE TO REMOVE PERCLOSE AFTER I WAS DEPLOYED. ANOTHER MD CAME, UNABLE TO REMOVE THE PERCLOSE. PT TAKEN TO OPERATING ROOM FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261072 ABBOTT VASCULAR PERCLOSE DEVICE PERCLOSE DEVICE MGB ABBOTT VASCULAR 6101841

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention