BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 20733661 · Received November 20, 2024

    Report

    Report Number
    20733661
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    FIVE SEPARATE PERCLOSE DEVICE SUTURE FAILURES. FAILED PERCLOSES REMOVED FROM PATIENT AND NEW PERCLOSE DEVICES INSERTED AND DEPLOYED. FOUR FAILED FROM LOT NUMBER 4052341 AND ONE FAILED FROM LOT NUMBER 4040442.

    Description of Event or Problem · 0

    FIVE SEPERATE PERCLOSE DEVICE SUTURE FAILURES. FAILED PERCLOSES REMOVED FROM PATIENT AND NEW PERCLOSE DEVICES INSERTED AND DEPLOYED. FOUR FAILED FROM LOT NUMBER 4052341 AND ONE FAILED FROM LOT NUMBER 4040442.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313404 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 12673-03 4052341 ; 4040442

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown