BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2931519 · Received January 28, 2013

    Report

    Report Number
    2024168-2013-00426
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED BENT SHEATH WAS CONFIRMED AS ANALYSIS OF THE DEVICE REVEALED THAT THE SHEATH AT THE GUIDE ATTACHMENT WAS BENT TO THE RIGHT AT 90 DEGREES FROM THE TOP AXIS OF THE HANDLE. THE REPORTED INABILITY TO ACHIEVE ARTERIAL MARKING FROM THE DEVICE MARKER LUMEN WAS NOT CONFIRMED AS TESTING OF THE DEVICE MARKER LUMEN INDICATED THE DEVICE WAS PATENT. THE INABILITY TO ACHIEVE ARTERIAL MARKING FROM THE DEVICE MARKER LUMEN MAY HAVE BEEN THE RESULT OF THE BENT SHEATH. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 DIAGNOSTIC PROCEDURE, ARTERIOTOMY CLOSURE OF A MODERATELY TORTUOUS RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. PRIOR TO USE THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS INSERTED (INTO THE VESSEL) OVER A STANDARD GUIDE WIRE. THE GUIDE WIRE WAS REMOVED BEFORE THE EXIT PORT OF THE DEVICE CROSSED THE SKIN LINE. REPORTEDLY, THE PHYSICIAN TRIED TO ADVANCE THE PROGLIDE DEVICE STRAIGHT INTO THE ARTERY COAXIAL TO THE TISSUE TRACT, BUT NO ARTERIAL FLOW WAS VISIBLE THROUGH THE MARKER LUMEN. WHEN THE DEVICE WAS RETRACTED THE PROXIMAL SHEATH WAS NOTED TO BE BENT. A SECOND PROGLIDE DEVICE WAS USED 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
    37638 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20914J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 5-FRENCH