BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1023546 · Received March 31, 2008

    Report

    Report Number
    2953144-2008-00226
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ABBOTT VASCULAR - REDWOODY CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEVED. INVESTIGATION IS NOT YET COMPLETE. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO. THE PERCLOSE PROGLIDE, PART # 12673-03, LOT # 57022-6H, IS BEING FILED UNDER A SEPARATE MFR REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE #1 MALFUNCTION: CUFF MISS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PHYSICIAN PULLED THE NEEDLE PLUNGER OUT, NO SUTURE WAS PRESENT. A SECOND PROGLIDE DEVICE WAS ATTEMPTED WITH THE SAME RESULT. A STARCLOSE VASCULAR CLOSURE SYSTEM WAS USED TO ACHIEVE HEMOSTASIS. INSPECTION OF THE DEVICE BY THE ACCOUNT MANAGER REVEALED THAT THE SECOND PROGLIDE DEVICE POSTERIOR FOOT WAS DETACHED AND WAS NOT RETURNED FOR ANALYSIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO 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 - REDWOODY CITY NA 57022-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT # 57022-6H| STARCLOSE