BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR

    MDR report key: 442499 · Received February 13, 2003

    Report

    Report Number
    442499
    Event Type
    Malfunction
    Date Received
    February 13, 2003
    Date of Event
    December 26, 2002
    Report Date
    December 26, 2002
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PERCLOSE DEVICE DID NOT DEPLOY PROPERLY - SUTURE BROKE AND WAS COMPLETELY REMOVED FROM BODY. (DEVICE DEPLOYED BY M.D.) SECOND PERCLOSE DEVICE USED, DEPLOYED WITHOUT PROBLEMS. R GROIN ARTERIAL SITE WITHOUT BLEEDING OR HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR PERCLOSE AT MGB ABBOTT VASCULAR DEVICES REF 12337 95052-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other