BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2122379 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04150
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER WITH THE ANTERIOR NEEDLE TIP, CUFFS AND LINK WERE NOT RETURNED. THE COMPLETE SUTURE WITH THE POSTERIOR NEEDLE TIP WAS LOADED IN THE DEVICE. THE POSTERIOR NEEDLE TIP WAS EXAMINED AND THERE WERE NO WITNESS MARKS OR DAMAGES DETECTED TO INDICATE CUFF CAPTURE, NEEDLE DETACHMENT OR STRIKING OF THE FOOT HAD OCCURRED. BOTH ENDS OF THE FOOT WERE EXAMINED AND THERE WERE NO NEEDLE STRIKE MARKS DETECTED. THIS FINDING INDICATES THE NEEDLE WAS DEFLECTED AWAY FROM THE FOOT AND CONFIRMS THE REPORTED CUFF MISS OCCURRED. DURING TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND THE RESULT WAS ACCEPTABLE. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED DURING MANUFACTURING. A CUFF-MISS CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT IS 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 PLUNGER/NEEDLE DEPLOYMENT, DEPLOYMENT IN A CHALLENGING ANATOMY, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT, AGAINST THE ARTERIAL WALL. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL NONCONFORMING MATERIAL RECORDS THAT WOULD HAVE AFFECTED THE REPORTED NEEDLE TO CUFF MISS IN THIS CASE. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE ANALYSIS OF THE DEVICE AND INSPECTION CRITERIA, THE CUFF MISS EXPERIENCED DURING THE PROCEDURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY PROBLEM. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PERCLOSE PROGLIDE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 030066H

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention