BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE CLOSURE (SMC) SYSTEM

    MDR report key: 1059705 · Received June 12, 2008

    Report

    Report Number
    2953144-2008-01040
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 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
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT YET COMPLETE. DEVICES #1, 3, 4, AND 5- PROGLIDE (PART #12673-05; LOT #62153-6H). IS BEING FILED UNDER MEDWATCH REPORTS. DEVICE #1-2953144-2008-001039 AND DEVICES #3, 4 AND 5 UNDER A SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: CUFF MISS (DEVICE #2). 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 PROGLIDE DEVICE WAS REMOVED AND FOUR PROGLIDE DEVICES WERE ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A PERCLOSE AT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 62153-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention PROGLIDE (PART #12673-05, LOT #62153-6H)| VESSEL CLOSURE: DEVICE #1