BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2073110 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03014
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE INDICATED THAT THE POSTERIOR CUFF MISS OCCURRED AS THE POSTERIOR CUFF WAS REMAINING IN THE FOOT POCKET. THE POSTERIOR NEEDLE TIP WAS RELEASED FROM THE SHANK BUT REMAINED UNDISTURBED, SUGGESTING THAT IT WAS DEFLECTED AWAY FROM THE POSTERIOR FOOT INSTEAD OF ENGAGED WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET DURING NEEDLE DEPLOYMENT AS DESIGNED. 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 ANTERIOR CUFF DETACHING FROM THE NEEDLE AS INDICATED BY DAMAGED ANTERIOR CUFF TABS AND ANTERIOR NEEDLE BARB. POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF DETACHMENT WOULD DIRECTLY RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING THE NEEDLE PLUNGER RETRACTION AS REPORTED. DURING TESTING, THE PLUNGER WAS REINSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS MET THE MANUFACTURING CRITERIA. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. BASED ON THE SUCCESSFUL TEST OF THE DEVICES, 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, AS SPECIFIED IN THE INSTRUCTIONS FOR USE (IFU). NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED.

    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. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    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, AFTER NEEDLE DEPLOYMENT, THE SUTURES WERE NOT RETRIEVED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. 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 010136H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention