BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1051053 · Received May 22, 2008

    Report

    Report Number
    2953144-2008-00929
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 29, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. DEVICE #1 PROGLIDE (LOT # 62137-6H) IS BEING FILED UNDER MEDWATCH REPORT 2953144-2008-00928.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: MARKER LUMEN BLOCK. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING TO USE THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THERE WAS NO BLEEDING FROM THE MARKER LUMEN TO INDICATE THE DEVICE WAS IN THE VESSEL. THE GUIDE WIRE WAS RE-INSERTED AND THE DEVICE WAS FLUSHED APPROXIMATELY THREE TIMES TO TRY TO GET BLOOD RETURN THROUGH THE MARKER LUMEN; WITHOUT SUCCESS. A SECOND PROGLIDE WAS ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING AN ANGIO-SEAL. FURTHER INFORMATION INDICATED THAT DURING DEVICE PREPARATION, THE FLUSHING SEEMED UNSUCCESSFUL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION 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 62137-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LOT #62137-6H| VESSEL CLOSURE DEVICE #1 - PROGLIDE