BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1080370 · Received July 22, 2008

    Report

    Report Number
    2953144-2008-01229
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 30, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #1 PROGLIDE PART# 12673-03, LOT #65167-6H IS BEING FILED UNDER MEDWATCH MFR #2953144-2008-01228. THE DEVICE HAS BEEN RETURNED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #2 SUTURE RETRIEVAL. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, UPON WITHDRAWAL OF THE PLUNGER THE "SUTURES DID NOT CATCH". THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING AN ANGIOSEAL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 65167-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LOT #65167-6H| DEVICE #1 PROGLIDE PART # 12673-03