BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131819 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04271
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE FIRST PROGLIDE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE ANTERIOR CUFF WAS ENGAGED TO THE ANTERIOR NEEDLE TIP AND BOTH CUFFS WERE ATTACHED TO THE LINK. THE POSTERIOR CUFF WAS OUT OF THE POCKET AND THE POSTERIOR CUFF TABS WERE UNDISTURBED, INDICATING THAT A POSTERIOR CUFF MISS OCCURRED. THERE WAS NO NEEDLE STRIKE MARK ON THE POSTERIOR FOOT. DURING THE INVESTIGATION, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY, NEEDLE DEPTH AND PUSH MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED DURING THE MANUFACTURING. BASED ON THE INVESTIGATION FINDINGS, THE MOST PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. A REVIEW OF THE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE WERE NO OTHER COMPLAINTS WITHIN THIS LOT FOR REPORTED FOR PLUNGER POPPING BACKWARDS ALMOST OUT OF THE DEVICE AFTER IT WAS DEPRESSED.

    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 LEVER WAS PULLED UP TO DEPLOY THE FOOT AND WHEN THE NEEDLE PLUNGER DEPRESSED IT "POPPED BACKWARDS" ALMOST OUT OF THE DEVICE. THE LEVER WAS PUSHED BACK DOWN AGAINST THE BODY OF THE DEVICE TO RETRACT THE FOOT AND THE DEVICE WAS REMOVED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. 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-TEMECULA-CT 010366H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention