BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2191742 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05501
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 SUMMARY: EVALUATION FOUND THAT THE SUTURE, POSTERIOR CUFF, AND POSTERIOR NEEDLE TIP WERE NOT RETURNED WITH THE DEVICE. WITHOUT THE RETURN OF THESE COMPONENTS, THE SCOPE OF THIS INVESTIGATION WAS LIMITED. INSPECTION REVEALED A LINK BREAK AT THE SWAGE END OF THE POSTERIOR CUFF DURING NEEDLE PLUNGER RETRACTION WHICH SUBSEQUENTLY RESULTED IN A FAILURE TO RETRIEVE THE SUTURE AND COULD APPEAR VERY SIMILAR TO THE REPORTED CUFF MISS. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. A LINK BREAK SUGGESTED THAT THERE WAS RESISTANCE ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE. CONTRIBUTING FACTORS FOR A LINK BREAK DURING THE SUTURE RETRIEVAL PROCESS INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES. BECAUSE THE SUTURE WAS NOT RETURNED, IT COULD NOT BE DETERMINED IF THE SUTURE WAS DRAGGED THROUGH THE DEVICE WHILE RETRACTING THE NEEDLE PLUNGER WHICH COULD HAVE CONTRIBUTED TO A LINK BREAK. THERE WAS NO INDICATION THAT THE SUTURE OR LINK WAS DRAGGED THROUGH THE SUTURE BEARING. EVERY LINK ASSEMBLY IS APPROPRIATELY INSPECTED AND TESTED FOR PROPER ASSEMBLY DURING MANUFACTURING. DURING TESTING, THE PLUNGER WAS REINSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. THERE WERE NO REPORTED CHALLENGING ANATOMICAL CONDITIONS WHICH COULD HAVE CONTRIBUTED TO A LINK BREAK. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE NEEDLE PLUNGER WAS ABRUPTLY PULLED OUT OF THE DEVICE AFTER NEEDLE DEPLOYMENT WHICH COULD CAUSE THE LINK TO BREAK. BASED ON THE REPORTED INFORMATION AND THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE LINK BREAK AT THE SWAGE END OF THE POSTERIOR CUFF COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS REMOVED, NO SUTURE WAS ATTACHED, AN ANTERIOR CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. A 5FR CONVERTED TO A 6FR SHEATH WAS USED DURING INSERTION OF THE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 940406H

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention SHEATH: 5F TO 6FBIVALIRUDIN