BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1911225 · Received November 30, 2010

    Report

    Report Number
    2953144-2010-03043
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 12, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. ESTIMATED DATE (DATE OF EVENT REPORTED AS EITHER (B)(6) 2010 OR (B)(6) 2010). (B)(4). DEVICE #2 - PROGLIDE (PART #12673-03; LOT #930396H) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE PLUNGER, LINK, ANTERIOR NEEDLE, AND BOTH CUFFS WERE NOT RETURNED. WITHOUT THE RETURN OF ALL COMPONENTS, THE INVESTIGATION WAS LIMITED. INSPECTION REVEALED AN UNDISTURBED POSTERIOR NEEDLE AND AN UNRAVELED SUTURE KNOT. THIS IS INDICATIVE OF THE POSTERIOR NEEDLE BEING DEFLECTED AWAY FROM THE POSTERIOR FOOT INSTEAD OF ENGAGED WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET DURING NEEDLE DEPLOYMENT. SUBSEQUENTLY, THE SUTURE KNOT WOULD NOT FORM TO BE ADVANCED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. DURING TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE SUTURE WAS DEPLOYED, HOWEVER, NO HEMOSTASIS WAS ACHIEVED. THE PROGLIDE DEVICE WAS REMOVED UNEVENTFULLY AND A SECOND PROGLIDE DEVICE WAS USED. THE PHYSICIAN COMMENTED THAT "THE PROGLIDE DEVICE WAS POSSIBLY INSERTED 'TOO FAR' IN TO THE ARTERY" BECAUSE WHEN THE DEVICE WAS BEING RETRACTED FOR PROPER POSITION THE "BACK WALL WAS PINCHED TO THE FRONT WALL". THE FOOT WAS PARKED AND THE DEVICE WAS REMOVED; HOWEVER, THE PATIENT PRESENTED WITH A "COLD FOOT" (DIMINISHED PULSE). THE PATIENT WAS TAKEN TO SURGERY AND A CUT DOWN PROCEDURE WAS PERFORMED AND HEMOSTASIS WAS ACHIEVED SURGICALLY. THE PATIENT IS REPORTED TO BE DOING FINE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, 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 SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY 930396H

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention DEVICE #2: PROGLIDE (PART #12673-03, LOT #930396H)