BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2000621 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01131
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE POSTERIOR PORTION OF THE FOOT WAS BROKEN OFF AND WAS NOT RETURNED. A POSTERIOR CUFF MISS ALSO OCCURRED BECAUSE THE POSTERIOR CUFF WAS NOT ENGAGED TO THE NEEDLE TIP. THE CUFF TABS WERE BENT AND UNDISTURBED. THE CUFF WAS SLIGHTLY DEFORMED AND MOST LIKELY THE RESULT OF THE CUFF REMAINING IN THE FOOT BEFORE IT BROKE. SINCE THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING, THE MOST PROBABLE ROOT CAUSE FOR THE POSTERIOR FOOT BREAK AND POSTERIOR CUFF MISS IS RELATED TO OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. PATIENT ANATOMICAL CONDITIONS SUCH AS OBESITY AND CALCIFICATION CAN INTERFERE WITH NEEDLE DEPLOYMENT, CAUSING THE NEEDLE TO DEFLECT AND STRIKE THE FOOT, BREAKING IT. CALCIFICATION OR OTHER BODY MATERIAL TRAPPED UNDER THE FOOT DURING DEPLOYMENT CAN INTERFERE AND MAY BREAK THE FOOT. ALSO, FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING DEPLOYMENT CAN PUT PRESSURE ON THE FOOT CAUSING IT TO BREAK. THE MARKING PATENCY WAS PERFORMED DURING THE INVESTIGATION AND THE MARKER TUBE WAS PATENT. THE REPORTED EVENT COULD NOT BE VERIFIED OR CONFIRMED. THE PROBABLE ROOT CAUSE FOR BLOCKED MARKER LUMEN IS LOW BLOOD PRESSURE, MARKER PORT NOT BEING IN THE ARTERIAL LUMEN, MARKER PORT AGAINST THE PATIENT ARTERY OR A SMALL PATIENT VESSEL DIAMETER. 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.

    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 PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AS THE DEVICE WAS PLACED, BLOOD DID NOT EXIT THE MARKER LUMEN. THE DEVICE WAS REMOVED AND MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. AFTER THE PROCEDURE, THE DEVICE WAS DEPLOYED TO TEST IT. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 950246H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention