BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1062448 · Received June 18, 2008

    Report

    Report Number
    2953144-2008-01055
    Event Type
    Injury
    Date Received
    June 18, 2008
    Report Date
    May 26, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. DEVICE #2 - PROGLIDE (PART#12673-05; LOT#63038-6H), DEVICE #3 - PROGLIDE (PART#12673-05; LOT#63056-6H), ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: CUFF MISS (DEVICE #1). 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 PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND TWO ADD'L PROGLIDE DEVICES WERE ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADD'L 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 63038-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PART#12673-05, LOT#63038-6H| VESSEL CLOSURE: DEVICE#: 2 - PROGLIDE| DEVICE #3 - PROGLIDE (PART#12673-05,LOT#63056-6H)| OTHER: PLAVIX