BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 10288630 · Received July 17, 2020

    Report

    Report Number
    10288630
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    June 18, 2020
    Report Date
    June 29, 2020
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    6 FR PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM, (REF # 12673-03), LOT #0031141, EXP 2022-01-31. FAILED @ END OF PERCUTANEOUS FEVAR PROCEDURE IN HYBRID OPERATING ROOM. THIS RESULTED IN EMERGENT CUTDOWN TO CONTROL BLEEDING FROM LEFT COMMON FEMORAL ARTERY. PER OPERATIVE REPORT, COMPLICATIONS: FAILED PRECLOSURE AND DIRECT MANUAL PRESSURE OF LEFT FEMORAL ARTERY REQUIRING OPEN EXPOSURE AND PRIMARY REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756485 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03 0031141

    Patients

    Seq Age Sex Outcome Treatment
    1 28835 DA Other| R