BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 6961134 · Received October 19, 2017

    Report

    Report Number
    6961134
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    October 3, 2017
    Report Date
    October 9, 2017
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648013089
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, PHYSICIAN REMOVED 14 F SHEATH (WITH THE DILATOR IN PLACE) AND STARTED TO COMPLETE THE PER-CLOSE, HOWEVER, THERE WAS MARKED BLEEDING AND THE PERCLOSE SUTURE SLIP KNOTS WOULD NOT SLIDE DOWN. PHYSICIAN HAD TROUBLE WITH THE DEPLOYMENT OF THREE OF THEM IN A ROW INITIALLY - HAVING TO PULL VERY HARD TO PULL THE SUTURES EVEN OUT OF THE BASE OF THE DEVICE. I FELT THE BLEEDING WAS RELATED TO A PROBLEM WITH THESE PARTICULAR PERCLOSE SUTURES AND WE QUICKLY PUT A 14F SHEATH BACK INTO THE ARTERY OVER THE WIRE THAT WAS NEVER REMOVED. ALL THREE OF THESE DEVICES CONTAIN THE SAME LOT #. ALL DEVICES FROM THIS LOT NUMBER FOR A TOTAL OF 8 (THREE USED AND 5 IN PACKAGE) HAVE BEEN SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740883 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03 7081041 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Other