BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE

    MDR report key: 7556342 · Received May 31, 2018

    Report

    Report Number
    7556342
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    March 22, 2018
    Report Date
    May 24, 2018
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED DEPLOYMENT OF THREE SEPARATE PERCLOSE DEVICES, NOT YIELDING BLOOD RETURN AS ANTICIPATED, COMPANY REPRESENTATIVE CONTACTED, ADVISED TO PROCEED, HOWEVER DOCTOR WAS UNCOMFORTABLE WITH USING DEVICE, REMOVED FROM THE BODY, PATIENT UNHARMED, REMAINED IN STABLE CONDITION, NO MEDICAL FOLLOW UP NECESSARY DUE TO EQUIPMENT. PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM. DOCTOR UNABLE TO DEPLOY THE PERCLOSE DEVICE; NO HARM TO PATIENT. REPS WILL BE AVAILABLE TO SHOW DOCTOR PROPER TECHNIQUE ALONG WITH STAFF IN THE USE OF PERCLOSE. LOT # 8020741; MANUFACTURER: ABBOTT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400079 PERCLOSE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 8020741

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR