BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2083572 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03358
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED PRODUCT EXPERIENCE. IT WAS NOTED THAT A POSTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. THE POSTERIOR NEEDLE TIP REMAINED WITH THE NEEDLE SHANK, INDICATING THAT THE PLUNGER WAS NOT FULLY DEPRESSED TO EJECT THE POSTERIOR NEEDLE OUT OF THE SHANK DURING NEEDLE DEPLOYMENT. THIS COULD HAVE BEEN CAUSED BY THE POSTERIOR NEEDLE INTERACTING WITH HUMAN TISSUE DURING NEEDLE DEPLOYMENT, PREVENTING THE PLUNGER FROM BEING FULLY DEPRESSED AND RESULTING IN BENT POSTERIOR NEEDLE FOLLOWER AT THE PROXIMAL END AS OBSERVED. BECAUSE THE POSTERIOR NEEDLE DID NOT ENGAGE WITH THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE LINK DETACHING AT THE SWAGE END OF THE ANTERIOR CUFF AS OBSERVED. DURING LAB TESTING, THE PLUNGER WAS REINSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS MET THE MANUFACTURING CRITERIA. THE POSTERIOR CUFF SUCCESSFULLY CAPTURED THE POSTERIOR NEEDLE AND BOTH WERE EJECTED OUT OF POCKET DURING PLUNGER REINSERTION AS INTENDED. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. BASED ON THE SUCCESSFUL TEST OF THE DEVICE, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT LINK DETACHMENT IS NEEDLE DEFLECTION DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS, THEY ARE SUBJECT TO A 100% INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    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 WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION. THE OTHER PERCLOSE IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE AT DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A MODERATELY CALCIFIED RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PERCLOSE AT WAS USED BUT A CUFF MISS OCCURRED AS WELL. A NON- ABBOTT DEVICE WAS USED TO ACHIEVE HEMSOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 960186H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention