BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2202862 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05681
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 18, 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). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE POSTERIOR CUFF MISS OCCURRED DURING NEEDLE DEPLOYMENT AS EVIDENCED BY UNDISTURBED POSTERIOR CUFF TABS AND UNDAMAGED POSTERIOR NEEDLE, INDICATING NO ENGAGEMENT BETWEEN THESE TWO COMPONENTS. THE POSTERIOR NEEDLE TIP WAS EJECTED FROM THE NEEDLE SHANK BUT REMAINED UNDISTURBED, SUGGESTING 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. THE POSTERIOR CUFF MISS WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING THE NEEDLE PLUNGER RETRACTION AND COULD APPEAR VERY SIMILAR TO THE REPORTED SUTURE BREAK. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WAS NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. POSSIBLE CONTRIBUTING FACTORS FOR THE NEEDLE DEFLECTION THAT RESULTED IN THE POSTERIOR CUFF MISS INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES. HOWEVER, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED TWICE DURING MANUFACTURING. ALSO, DURING TESTING, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. ALTHOUGH, THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST INCORRECT DEPLOYMENT TECHNIQUE, BASED ON THE SUCCESSFUL TEST OF THE DEVICES NEEDLE TRAJECTORY 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. ANALYSIS ALSO INDICATED THAT THE LEVER COULD NOT BE CLOSED TO RETRACT THE FOOT DUE TO THE BENT ACTUATOR WIRE. HOWEVER, A BENT ACTUATOR WIRE IS CONSISTENT WITH POST-PROCEDURE MANIPULATION; THEREFORE, WAS NOT CONSIDERED A FAILURE MODE OF THE DEVICE. DURING TESTING, THE FOOT WAS COMPLETELY CLOSED BY PUSHING THE PROXIMAL END OF THE ACTUATOR WIRE. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY RELEVANT NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE SUTURE BROKE. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 040366H

    Patients

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