BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1172115 · Received September 23, 2008

    Report

    Report Number
    2953144-2008-01548
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 2, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #2: PERCLOSE PROGLIDE, PART #12673-05, LOT #50072-6H WILL BE FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #1 UNKNOWN DEVICE FAILURE. 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 A HEAVILY CALCIFIED FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PHYSICIAN COMPLETED ALL THE STEPS IN THE INSTRUCTIONS FOR USE (IFU), BUT NOTICED THAT THE PUNCTURE SITE IN THE ARTERY WAS NOT CLOSED. A SECOND PROGLIDE WAS ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    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 50072-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT# 50072-6H| DEVICE #2 PERCLOSE PROGLIDE PART# 12673-05