BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1984375 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00815
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT A POSTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET AND THE POSTERIOR NEEDLE BEING UNDISTURBED. BECAUSE THE POSTERIOR NEEDLE DID NOT ENGAGE WITH THE POSTERIOR CUFF DURING NEEDLE DEPLOYMENT, 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 ANTERIOR CUFF DETACHING FROM THE NEEDLE AS INDICATED BY DAMAGED ANTERIOR CUFF TABS AND NEEDLE BARB. DURING TESTING, THE PLUNGER WAS REINSERTED 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 AND SUBSEQUENT ANTERIOR CUFF TO NEEDLE TIP DETACHMENT 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. CHALLENGING ANATOMICAL CONDITIONS SUCH AS CALCIFICATION, SCARS, OR TORTUOSITY CAN DEFLECT THE NEEDLES DURING NEEDLE DEPLOYMENT. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. 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 PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY AFTER A RIGHT AND LEFT HEART CATHETERIZATION. REPORTEDLY, AN ANTERIOR CUFF MISS OCCURRED. TWO ADDITIONAL PROGLIDES WERE USED WITH THE SAME RESULTS. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THE RIGHT COMMON FEMORAL ARTERY HAD SCAR TISSUE PRESENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 930296H

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention