BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1972836 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00504
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACILITY REPORTED TWO MORE CASES (MEDWATCH REPORTS: 2024168-2011-00503 AND 2024168-2011-00505) DESCRIBING THE SAME FAILURE MODE OF CUFF MISS AND ALL THREE DEVICES USED BY THE SAME PHYSICIAN. ALL THREE DEVICES WERE GIVEN TO THE MANUFACTURER REPRESENTATIVE FOR RETURN IN A SINGLE BAG, THEREFORE THEY CAN NOT BE CORRELATED TO EACH CASE. EVALUATION SUMMARY: EVALUATION NOTED THAT THE PLUNGER, SUTURE, ANTERIOR CUFF, AND NEEDLES WERE NOT RETURNED WITH THE DEVICE; LIMITING THE SCOPE OF THIS INVESTIGATION. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE POSTERIOR CUFF REMAINED IN THE POCKET AND THERE WAS A NEEDLE STRIKE MARK AT THE POSTERIOR FOOT, THIS IS CONSISTENT WITH THE POSTERIOR NEEDLE STRIKING THE FOOT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE FOOT POCKET DURING NEEDLE DEPLOYMENT. THEREFORE, THE REPORTED CUFF MISS IS CONFIRMED. BECAUSE THE POSTERIOR NEEDLE DID NOT ENGAGE WITH THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE LINK BREAK AT THE SWAGE END OF THE ANTERIOR CUFF. DURING LAB TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS WERE ACCEPTABLE. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. BASED ON THE SUCCESSFUL NEEDLE TRAJECTORY TESTING IN THE LAB TEST AND TESTING DURING MANUFACTURING, THE PROBABLE ROOT CAUSE FOR THE POSTERIOR POSTERIOR CUFF MISS AND SUBSEQUENT LINK BREAK AT THE ANTERIOR CUFF 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 ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF A MODERATELY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED, THE PHYSICIAN PULLED THE PLUNGER BACK AND NO SUTURE WAS ATTACHED TO IT. A SECOND PROGLIDE WAS SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. 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 950056H

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention HEPARIN