BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2141764 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04510
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PROGLIDE DEVICE FOUND THAT THE ENTIRE MONOFILAMENT WAS RETURNED LOOSE AND THE NEEDLE TIP REMAINED ATTACHED TO THE RAIL-END OF THE SUTURE. THE NEEDLE PLUNGER, LINK, ANTERIOR AND POSTERIOR CUFFS WERE NOT RETURNED WITH THE DEVICE, WHICH LIMITED THE SCOPE OF THE INVESTIGATION. BASED ON THE FINDINGS, A POSTERIOR NEEDLE-TO-CUFF MISS OCCURRED AS INDICATED BY THE POSTERIOR NEEDLE TIP BEING RETURNED WITHOUT THE POSTERIOR CUFF. THERE WAS NO NEEDLE STRIKE MARK ON THE POSTERIOR FOOT. DURING TESTING, A PROXY NEEDLE PLUNGER WAS INSERTED RESULTING IN ACCEPTABLE NEEDLE TRAJECTORY. IN ADDITION, TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING THE MANUFACTURING. THE MOST PROBABLE ROOT CAUSE FOR THE POSTERIOR NEEDLE-TO-CUFF MISS IS NEEDLE DEFLECTION DURING NEEDLE 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 DURING NEEDLE DEPLOYMENT. A NEEDLE-TO-CUFF-MISS CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING NEEDLE PLUNGER DEPLOYMENT, DEPLOYMENT IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING OR REMOVING THE NEEDLE PLUNGER OR INADEQUATE POSITIONING OF THE FOOTPLATE AGAINST THE ARTERIAL WALL. BASED ON THE DEVICE EVALUATION, THE MOST PROBABLE ROOT CAUSE FOR THE POSTERIOR NEEDLE-TO-CUFF MISS IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS THAT WOULD HAVE AFFECTED THE REPORTED NEEDLE-TO-CUFF MISS IN THIS CASE. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    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 THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A CORONARY STENTING PROCEDURE OF THE RIGHT CORONARY ARTERY. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS ATTACHED TO THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE PROGLIDE. 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 030106H

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention