BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1032135 · Received April 18, 2008

    Report

    Report Number
    2953144-2008-00743
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. DEVICE #1: PROGLIDE PART# 12673-03, LOT# 57124-6H IS BEING FILED UNDER MEDWATCH MFR# 2953144-2008-00742.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: POSTERIOR CUFF MISS. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE AND PERCLOSE A-T DEVICES ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PERIPHERAL PROCEDURE. REPORTEDLY, WHEN THE PHYSICIAN PULLED THE NEEDLE PLUNGER OUT OF THE PROGLIDE, NO SUTURE WAS PRESENT; A POSTERIOR CUFF MISS OCCURRED. THE DEVICE WAS REMOVED. AN ATTEMPT WAS MADE USING A PERCLOSE A-T, WHICH RESULTED IN A POSTERIOR CUFF MISS. A THIRD DEVICE, A PROGLIDE WAS USED AND SUCCESSFULLY ACHIEVED HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 57070-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention DEVICE#1:PROGLIDE PART# 12673-03