BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE

    MDR report key: 23872169 · Received December 22, 2025

    Report

    Report Number
    MW5180999
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 10, 2025
    Report Date
    December 15, 2025
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PERCLOSE DEPLOYED ON THE RIGHT FEMORAL ARTERY BUT UPON INSPECTION OF THE "2 FEET" ONLY 1 FOOT WAS NOTED. MD WAS NOTIFIED; PULSES WERE CHECKED ON THE PATIENT WHICH WAS (2+). MD CONSULTED WITH VASCULAR. PER VASCULAR MD- NO INTERVENTION NEEDED AND TO MONITOR THE PATIENT. ITEM DESCRIPTION: PERCLOSE EXP: 8/31/2027; REF: 12673-03; LOT: 5101841.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2696115 PERCLOSE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 5101841

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male