BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2110734 · Received June 1, 2011

    Report

    Report Number
    2024168-2011-03830
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE DEVICE WAS PARTIALLY DEPLOYED. ONLY THE BODY OF THE DEVICE AND THE PLUNGER WERE RETURNED. THE ANTERIOR CUFF WAS RETURNED IN THE FOOT POCKET WITH ITS TABS INTACT. THIS FINDING INDICATES THE NEEDLE WAS DEFLECTED AWAY FROM THE FOOT POCKET DURING DEPLOYMENT. BOTH OF THE FOOT POCKETS WERE EXAMINED AND NO NEEDLE STRIKE MARKS WERE DETECTED. APPROXIMATELY 4 MM OF THE LINK WAS ATTACHED TO THE ANTERIOR CUFF THE REMAINING PORTION HAD BEEN BROKEN OFF. THESE FINDINGS ARE CONSISTENT WITH AND CONFIRM THE REPORTED CUFF MISS EXPERIENCE. DURING TESTING THE RETURNED PLUNGER WAS INSERTED AND THE NEEDLE TRAJECTORY, DEPTH AND MANDREL TRAVEL WERE ACCEPTABLE. THE ANTERIOR CUFF WAS CAPTURED (ATTACHED TO THE NEEDLE TIP) DURING TRAJECTORY TESTING. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE SUTURE WOULD NOT BE PRESENT IN THIS CASE. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED DURING MANUFACTURING. A CUFF-MISS CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; MANUFACTURING (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), 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 CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. BASED ON THE REPORTED INFORMATION, INVESTIGATION FINDINGS, TEST RESULTS AND INSPECTION CRITERIA, THE NEEDLE TO CUFF MISS EXPERIENCED DURING THE PROCEDURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY PROBLEM. NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY WAS DETECTED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. 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 THE DEVICES ARE SUBJECT TO INSPECTION DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE 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 THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, A CUFF MISS OCCURRED. THE PROGLIDE WAS REMOVED AND THE METHOD THAT HEMOSTASIS WAS ACHIEVED WAS NOT REPORTED. 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 A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 950116H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention