BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 24638191 · Received March 19, 2026

    Report

    Report Number
    24638191
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 3, 2026
    Report Date
    March 13, 2026
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CAME THROUGH OUTPATIENT CENTER FOR AFIB (ATRIAL FIBRILLATION) ABLATION; PERCLOSE CLOSURE DEVICE DELIVERED TO RIGHT FEMORAL VEIN X4 WITH NO ISSUE AND TRANSFERRED TO CATH LAB HOLDING FOR RECOVERY AND THEN TRANSFERRED BACK TO SDCC (SURGICAL DAY CARE CENTER). SDCC CALLED WITH COMPLAINTS THAT PATIENT WAS BLEEDING AND PRESSURE WAS BEING HELD. ABBOTT PERCLOSE PROSTYLE; LOT # 5120642; EXP: 11/30/27; VASCADE LOT# G612C250526B; EXP: 5/19/27. MANUFACTURER RESPONSE FOR CLOSURE DEVICE, PERCLOSE & VASCADE (PER SITE REPORTER): THE DEVICE REP CAME ON SITE TO OBSERVE USE AND PROVIDE ADDITIONAL INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706443 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 12773-03 5120642

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Other