BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGLIDE

    MDR report key: 22610777 · Received July 25, 2025

    Report

    Report Number
    MW5173288
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    July 19, 2025
    Report Date
    July 22, 2025
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ABBOTT PERCLOSE CLOSURE DEVICE LOT #5051741 BROKE DURING DEPLOYMENT WITH THE TIP RETAINED WITHIN THE PATIENTS' ARTERY. A SECOND ABBOTT PERCLOSE DEVICE LOT # 5051741 BROKE BUT TIP WAS NOT RETAINED. CV SURGEON CONSULTED AND RETAINED TIP REMOVED SURGICALLY. ALL ABBOTT PERCLOSE LOT #5051741 REMOVED FROM CIRCULATION AND ABBOTT NOTIFIED. REF REPORT: MW5173289.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966747 PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 5051741

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention