BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2103423 · Received May 26, 2011

    Report

    Report Number
    2024168-2011-03703
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 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
    BE
    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: THE DEVICE WAS RETURNED PARTIALLY DEPLOYED. BOTH CUFFS HAD BEEN CAPTURED AND ATTACHED TO THE NEEDLE TIPS. HOWEVER, THE LINK WAS PULLED FROM THE POSTERIOR CUFF DURING SUTURE DEPLOYMENT. ALTHOUGH A LINK BREAK DURING NEEDLE RETRIEVAL AND A CUFF MISS HAVE THE SAME RESULT AND APPEARANCE DURING DEPLOYMENT, THE REPORTED CUFF MISS EXPERIENCE CANNOT BE CONFIRMED, BECAUSE BOTH CUFFS WERE CAPTURED. DURING NEEDLE TRAJECTORY TESTING, THE PLUNGER WAS INSERTED INTO THE DEVICE AND THE TRAJECTORY, DEPTH AND MANDREL TRAVEL WERE ACCEPTABLE AND NOT A CONTRIBUTING FACTOR IN THE EVENT. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED DURING MANUFACTURING. WHEN THE SUTURE IS HARVESTED AND PULLED THROUGH THE SUTURE BEARING AND ANTERIOR NEEDLE GUIDE; RESISTANCE AT ANY POINT OF DEPLOYMENT CAN CAUSE THE LINK TO DETACH. A LINK DETACHMENT 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 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. BASED ON THE INVESTIGATION AND THE INSPECTION CRITERIA THE LINK DETACHMENT EXPERIENCED DURING THE PROCEDURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY PROBLEM. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS EVENT. 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. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, 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 AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. 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 960286H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention