BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROSTYLE

    MDR report key: 24930873 · Received April 20, 2026

    Report

    Report Number
    MW5186999
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 15, 2026
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PERCLOSE PROSTYLE-SUTURE MEDIATED CLOSURE AND REPAIR SYSTEM, (B)(4), LOT: 5120543, REF: 12773-03. PROVIDER STATES THAT SUTURES TORE WHEN THEY WERE CLOSING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147927 PERCLOSE PROSTYLE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 12773-03 5120543

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female