BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 12127235 · Received July 7, 2021

    Report

    Report Number
    12127235
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    November 11, 2020
    Report Date
    June 24, 2021
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM DID NOT DEPLOY CORRECTLY. ANOTHER DEVICE WAS AVAILABLE AND USED, NO HARM TO PATIENT, DEVICE REF# (B)(4), LOT #0061341.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027063 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03 0061341

    Patients

    Seq Age Sex Outcome Treatment
    1 33215 DA