BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1973217 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00536
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 7, 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
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT HAD BEEN FULLY DEPLOYED. THE HANDLE, GUIDE TUBE, GUIDE, FOOT AND SHEATH WERE UNDAMAGED AND BLOW THROUGH MARKS WERE NOTED ON THE POSTERIOR FOOT. THE RETURNED PLUNGER WAS UNDAMAGED AND THE SUTURE, COMPLETE AND UNDAMAGED, WAS FULLY FREE OF THE DEVICE HANDLE WITH ITS POSTERIOR NEEDLE TIP ENGAGED WITH THE POSTERIOR CUFF, EJECTED FROM THE POSTERIOR FOOT, WITH THE LINK AND ANTERIOR CUFF ATTACHED. THE ANALYSIS INDICATED THAT AN ANTERIOR NEEDLE TO ANTERIOR CUFF DETACHMENT HAD OCCURRED, BREAKING TWO OF THE CUFF TABS OFF THE CUFF AND BENDING ONE TAB. THE BROKEN OFF CUFF TABS (MEASURING APPROXIMATELY .01 X .01 SQUARE INCH EACH) WERE NOT RETURNED. THERE WAS A WITNESS MARK OBSERVED ON THE ANTERIOR NEEDLE TIP, HOWEVER, NO CORRESPONDING WITNESS MARK WAS DETECTED WITHIN THE ANTERIOR FOOT POCKET. THIS INDICATED THE ANTERIOR NEEDLE TIP HAD PROPERLY ENTERED AND ENGAGED THE ANTERIOR CUFF AND DURING THE RETRACTION PROCESS OF THE PLUNGER/NEEDLES ASSEMBLY FROM THE DEVICE HANDLE, THE CUFF TO NEEDLE DETACHMENT OCCURRED. THERE WAS NO DETECTED DAMAGE TO THE HANDLE OR ITS COMPONENTS TO INDICATE RESISTANCE TO SUTURE DEPLOYMENT THROUGH THE DEVICE. THE POSTERIOR NEEDLE TO POSTERIOR CUFF ENGAGEMENT WAS SECURE. THE DEVICE NEEDLE TRAJECTORY ALSO PRODUCED ACCEPTABLE RESULTS WITH INSERTION OF THE PLUNGER/NEEDLES ASSEMBLY INTO THE HANDLE ASSEMBLY ACHIEVING COMPLETE PLUNGER STROKE WITH ALL NEEDLE PARAMETERS MET: TRAJECTORY, DEPTH PENETRATION AND PUSH MANDREL TRAVEL. A POSSIBLE CAUSE FOR THE NEEDLE TO CUFF DETACHMENT MAY HAVE BEEN DUE TO INTERACTION WITH TISSUE, FAST ABRUPT PLUNGER WITHDRAWAL FROM THE HANDLE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING DEPLOYMENT. HOWEVER, A SECOND PROGLIDE DEVICE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS INDICATING A USER ISSUE WAS LIKELY NOT THE CAUSE. BASED ON THE INVESTIGATION NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED AND A ROOT CAUSE FOR THE DETECTED NEEDLE TO CUFF DETACHMENT AND THE REPORTED COMPLAINT IS UNDETERMINED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND IT HAD BEEN FULLY DEPLOYED. THE HANDLE, GUIDE TUBE, GUIDE, FOOT AND SHEATH WERE UNDAMAGED AND BLOW THROUGH MARKS WERE NOTED ON THE POSTERIOR FOOT. THE RETURNED PLUNGER WAS UNDAMAGED. THE SUTURE WAS SEVERELY DAMAGED WITH ITS POSTERIOR NEEDLE TIP ENGAGED WITH THE POSTERIOR CUFF, EJECTED FROM THE POSTERIOR FOOT, WITH THE LINK AND ANTERIOR CUFF ATTACHED. THE ANALYSIS INDICATED AN ANTERIOR NEEDLE TO ANTERIOR CUFF DETACHMENT HAD OCCURRED. PART OF THE CUFF CONTAINING TWO TABS WAS BROKEN OFF AND NOT RETURNED. THE REMAINING TAB WAS BENT. THE BROKEN OFF CUFF TABS MEASURED APPROXIMATELY .01 X .01 SQUARE INCH EACH. A BROKEN PIECE OF THE CUFF MEASURED APPROXIMATELY .0150 SQUARE INCH X .0133 SQUARE INCH. THERE WAS A WITNESS MARK OBSERVED ON THE ANTERIOR NEEDLE TIP, HOWEVER, NO CORRESPONDING WITNESS MARK WAS DETECTED WITHIN THE ANTERIOR FOOT POCKET. THIS INDICATED THE ANTERIOR NEEDLE TIP HAD PROPERLY ENTERED AND ENGAGED THE ANTERIOR CUFF AND DURING THE RETRACTION PROCESS OF THE PLUNGER/NEEDLES ASSEMBLY FROM THE DEVICE HANDLE, THE CUFF TO NEEDLE DETACHMENT OCCURRED. THE SUTURE WAS SEVERELY DAMAGED, SUGGESTING THAT IT MIGHT HAVE BEEN DRAGGED DURING THE PLUNGER REMOVAL WHICH COULD RESULT IN ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT AS DETECTED. THE POSTERIOR NEEDLE TO POSTERIOR CUFF ENGAGEMENT WAS SECURE. LAB TESTING OF THE DEVICE, TO CHECK ITS NEEDLE TRAJECTORY, ALSO PRODUCED ACCEPTABLE RESULTS WITH INSERTION OF THE PLUNGER/NEEDLES ASSEMBLY INTO THE HANDLE ASSEMBLY ACHIEVING COMPLETE PLUNGER STROKE WITH ALL NEEDLE PARAMETERS MET: TRAJECTORY, DEPTH PENETRATION AND PUSH MANDREL TRAVEL. THERE WAS NO OBSERVABLE RESISTANCE WHILE RETRACTING THE PLUNGER THAT MIGHT HAVE CAUSED THE ANTERIOR CUFF DETACHING FROM ITS NEEDLE. THEREFORE, BASED ON OUR INVESTIGATION, THE ROOT CAUSE FOR THE SUTURE DRAG THAT SUBSEQUENTLY RESULTED IN ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT COULD NOT BE DETERMINED. 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 WAS PERFORMED AND THERE WERE NO OTHER CASES OF A DETACHED ANTERIOR NEEDLE FROM THE ANTERIOR CUFF WITH THE SAME LOT NUMBER.

    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, PERIPHERAL PROCEDURE. REPORTEDLY, THE PHYSICIAN DEPLOYED THE DEVICE AND WHEN HE PULLED THE NEEDLES OUT THE SUTURES PULLED RIGHT OUT. ANOTHER PROGLIDE WAS SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, 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 940116H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN