BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131301 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04250
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 25, 2011
    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). EVALUATION SUMMARY: EVALUATION OF THE RETURNED COMPONENTS, THE BODY OF THE DEVICE, HANDLE TO FOOT FUNCTION, GUIDE TUBE, NEEDLE GUIDE, BRIDGE, SUTURE BEARING, EXIT RAMP AND SHEATH WERE NORMAL. THERE WAS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY THAT WOULD HAVE CONTRIBUTED TO THE REPORTED CUFF MISS. THE POSTERIOR CUFF WAS OUT OF THE FOOT AND THERE WAS A NEEDLE STRIKE MARK ON THE RIM OF THE CUFF. BOTH CUFFS WERE ATTACHED TO THE LINK AND THE ANTERIOR CUFF WAS ENGAGED TO ANTERIOR NEEDLE TIP. BASED ON THE EVIDENCE FOUND ON THE RETURNED DEVICE, THE POSTERIOR CUFF WAS MISSED AND THIS CONFIRMED THE REPORTED CUFF MISS. THERE WAS NO NEEDLE STRIKE MARK ON THE POSTERIOR FOOT. DURING TESTING, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY, NEEDLE DEPTH AND PUSH MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED DURING THE MANUFACTURING. BASED ON THE INVESTIGATION FINDINGS, THE MOST 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 DURING NEEDLE DEPLOYMENT. A QUERY FOR THIS LOT BASED ON ACTUAL INVESTIGATION FINDINGS WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS THAT EXHIBITED THE POSTERIOR CUFF MISS AND NEEDLE STRIKE ON THE CUFF AS THIS INCIDENT. A CUFF MISS FAILURE MODE IS GENERALLY ASSOCIATED WITH TECHNIQUE ISSUES OR PATIENT ANATOMICAL CONDITIONS. THE MULTIPLE OCCURRENCES OF THIS FAILURE MODE ARE NOT AN INDICATION OF A POTENTIAL PROBLEM WITH THIS LOT. A REVIEW OF THE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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 FIRST PROGLIDE AND THE STARCLOSE ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A SCARRED AND MODERATELY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AN ANTERIOR CUFF MISS OCCURRED. A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. A STARCLOSE WAS DEPLOYED, BUT FAILED TO ACHIEVE HEMOSTASIS. MANUAL ARTERIAL COMPRESSION WAS APPLIED 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 030426H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention