BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3802286 · Received May 9, 2014

    Report

    Report Number
    2024168-2014-02960
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE REFERENCED WAS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR MARKER LUMEN BLOCKAGE/INABILITY TO ACHIEVE DEVICE MARKING REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A VASCULAR EMBOLIZATION OF BONE TUMOR PROCEDURE, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, THE DEVICE WAS INSERTED OVER A GUIDE WIRE INTO THE VESSEL; THE GUIDE WIRE WAS REMOVED ONCE THE GUIDE WIRE EXIT PORT WAS AT THE SKIN LEVEL. THE OPERATOR CONTINUED TO INSERT THE DEVICE INTO ARTERY. ALTHOUGH, BLEEDING WAS OBSERVED OUT OF MARKER LUMEN, IT WAS NOT PULSATILE BLEEDING. THE OPERATOR TRIED INSERTING THE DEVICE FURTHER INTO ARTERY, FLUSHED THE MARKER LUMEN AGAIN, TURNED THE DEVICE SLIGHTLY, AND ALSO TRIED RETRACTING THE DEVICE, BUT NOTHING SEEMED TO GET GOOD PULSATILE BLOOD FLOW FROM THE MARKER LUMEN. A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT WITH THE SAME RESULTS, PULSATILE BLEEDING FROM THE DEVICE MARKER LUMEN WAS NOT PRESENT. THE DEVICE WAS REMOVED AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE IN-TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280708 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 31106K1

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SHEATH: 6-FRENCH