BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 7240670 · Received February 5, 2018

    Report

    Report Number
    7240670
    Event Type
    Malfunction
    Date Received
    February 5, 2018
    Date of Event
    January 28, 2018
    Report Date
    January 29, 2018
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE PROGLIDE 6 F PERCLOSE SUTURE-MEDIATED CLOSURE SYSTEM # 12673-03 WITH LOT NUMBERS 7110942 EXP DATE 09-30-2019 DID NOT DEPLOY. TWO OTHER PROGLIDES NEEDED TO BE OPENED IN ORDER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85740 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03 7110942

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR