BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1960067 · Received January 13, 2011

    Report

    Report Number
    2024168-2011-00274
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE SUTURE WAS NOT HARVESTED, BUT REMAINED INSIDE THE DEVICE, CONTRADICTING THE REPORTED INFORMATION. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE POSTERIOR CUFF MISS OCCURRED AS EVIDENCED BY UNTOUCHED POSTERIOR CUFF TABS AND UNDISTURBED POSTERIOR NEEDLE, INDICATING THAT NO ENGAGEMENT OCCURRED BETWEEN THESE TWO COMPONENTS DURING NEEDLE DEPLOYMENT. SUBSEQUENTLY, THE SUTURE COULD NOT BE RETRIEVED AND THE KNOT WOULD NOT FORM TO BE ADVANCED TO THE ARTERIAL SURFACE TO ACHIEVE HEMOSTASIS. DURING TESTING, THE PLUNGER WAS REINSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. BASED ON THE TESTING, THE PROBABLE 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. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION. THERE WERE NO NON-CONFORMING MATERIAL REPORTS ISSUED AGAINST THIS LOT.

    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, THE SUTURES WERE HARVESTED. WHILE REMOVING THE DEVICE, A FAST FLOW OF BLOOD WAS OBSERVED. IT WAS REPORTED THAT THE DEVICE DIDN'T CAPTURE THE VESSEL PROPERLY. MANUAL COMPRESSION WAS APPLIED 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 940226H

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention