BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2042019 · Received April 6, 2011

    Report

    Report Number
    2024168-2011-02408
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 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). 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 REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER, ANTERIOR NEEDLE, LINK, AND BOTH CUFFS WERE NOT RETURNED WITH THE DEVICE WHICH LIMITED THE SCOPE OF THE INVESTIGATION. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE POSTERIOR CUFF MISS HAD OCCURRED AS EVIDENCED BY THE UNDISTURBED POSTERIOR NEEDLE. THERE WAS NO NEEDLE STRIKE MARK OBSERVED AT THE POSTERIOR FOOT, SUGGESTING THAT THE POSTERIOR NEEDLE WAS DEFLECTED AWAY FROM THE POSTERIOR FOOT INSTEAD OF ENGAGED WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET DURING NEEDLE DEPLOYMENT AS DESIGNED. THE POSTERIOR CUFF MISS DURING NEEDLE DEPLOYMENT SUBSEQUENTLY RESULTED IN A FAILURE TO RETRIEVE THE SUTURE WHEN RETRACTING THE NEEDLE PLUNGER AS REPORTED. DURING TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT 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. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED.

    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, WHEN THE PLUNGER WAS PULLED BACK ONLY THE LINK WAS ATTACHED TO THE NEEDLE AND THE SUTURE AND LINK DID NOT CAPTURE THE ARTERY TO ACHIEVE HEMOSTASIS. A NON-ABBOTT DEVICE 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 950386H

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention