BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2250955 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06347
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 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). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE INDICATED THAT A POSTERIOR CUFF MISS OCCURRED DURING NEEDLE DEPLOYMENT AS EVIDENCED BY UNDISTURBED POSTERIOR CUFF TABS AND UNDISTURBED POSTERIOR NEEDLE, INDICATING NO ENGAGEMENT BETWEEN THE TWO COMPONENTS. THE POSTERIOR NEEDLE TIP WAS EJECTED FROM THE NEEDLE SHANK, BUT REMAINED UNDISTURBED, SUGGESTING THAT THE POSTERIOR NEEDLE WAS DEFLECTED AWAY FROM THE POSTERIOR FOOT INSTEAD OF ENGAGING 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 AS OBSERVED. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. POSSIBLE CONTRIBUTING FACTORS FOR NEEDLE DEFLECTION THAT CAN RESULT IN A POSTERIOR CUFF MISS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, CHALLENGING ANATOMICAL CONDITIONS, AND/OR DEPLOYMENT TECHNIQUES. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED DURING MANUFACTURING. DURING TESTING, THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL MET THE MANUFACTURING CRITERIA. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE DEVICE WAS TWISTED OR ROTATED OR THE NEEDLES WERE DEPLOYED WHEN THE DEVICE WAS NOT AT AN APPROXIMATE 45 DEGREE ANGLE, WHICH COULD HAVE CONTRIBUTED TO THE NEEDLE DEFLECTION. BASED ON THE SUCCESSFUL TESTING OF THE DEVICE, 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. THE PROBABLE CAUSE WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE PERFORMED FOR THIS LOT DID NOT REVEAL ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER AN DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND ANOTHER PROGLIDE 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 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 10802J1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SHEATH: 6F