BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2241197 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06231
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    June 2, 2011
    Report Date
    August 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE POSTERIOR NEEDLE TIP WAS EJECTED FROM THE NEEDLE SHANK BUT REMAINED UNDISTURBED, INDICATING THAT THE POSTERIOR NEEDLE WAS DEFLECTED AWAY FROM POSTERIOR FOOT INSTEAD OF ENGAGED WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET DURING NEEDLE DEPLOYMENT AS INTENDED. THE POSTERIOR CUFF MISS WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING THE PLUNGER RETRACTION AS OBSERVED. POSSIBLE CONTRIBUTING FACTORS FOR NEEDLE DEFLECTION THAT RESULTS IN THE POSTERIOR CUFF MISS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND/OR DEPLOYMENT TECHNIQUES. DURING THE MANUFACTURING PROCESS, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED. A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED WHICH COULD HAVE CONTRIBUTED TO THE DETECTED POSTERIOR CUFF MISS. ALSO, THERE WAS NO DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE DEVICE WAS TWISTED, ROTATED OR THAT THE NEEDLES WERE DEPLOYED WHEN THE DEVICE WAS NOT AT APPROXIMATELY 45-DEGREE ANGLE WHICH COULD HAVE CONTRIBUTED TO THE POSTERIOR CUFF MISS. BASED ON THE SUCCESSFUL TEST OF THE NEEDLE TRAJECTORY IN THE LAB AND DURING MANUFACTURING, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT 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. ANALYSIS OF THE RETURNED DEVICE SUBSTANTIATED THE REPORTED CUFF MISS AS IT INDICATED THAT A POSTERIOR CUFF MISS OCCURRED AND THE PROBABLE CAUSE WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED. THE ACCESS SITE WAS THE RIGHT COMMON FEMORAL ARTERY. ANOTHER PERCLOSE PROGLIDE WAS USED TO SUCCESSFULLY ACHIEVE HEMOSTASIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING THE PERCLOSE PROGLIDE DEVICE AFTER A PERIPHERAL ANGIOPLASTY PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND ANOTHER DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE DEVICE. NO ADDITIONAL INFORMATION 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 940266H

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention