BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR PROGLIDE PERCLOSE

    MDR report key: 11568414 · Received March 24, 2021

    Report

    Report Number
    MW5100251
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    March 17, 2021
    Report Date
    March 22, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A TAVR PROCEDURE, PHYSICIAN PLACED ABBOTT VASCULAR PROGLIDE PERCLOSE 6 FR. IN THE PATIENTS RIGHT FEMORAL ARTERY AND THE END OF THE PERCLOSE DEVICE BROKE OFF IN THE PATIENT'S RIGHT FEMORAL ARTERY. REFERENCE # (B)(4), LOT #: 1012141, EXP: 11/30/2022. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456479 ABBOTT VASCULAR PROGLIDE PERCLOSE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 12673-03 1012141

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR