BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2222379 · Received August 25, 2011

    Report

    Report Number
    2024168-2011-05934
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE DEVICE WAS FULLY DEPLOYED AND HAD DELIVERED THE SUTURE AS EVIDENCE BY BOTH CUFFS BEING CAPTURED. THE REPORTED INFORMATION INDICATED THE DIFFICULTY WAS EXPERIENCED AFTER THE SUTURE HAD BEEN RETRIEVED AND DURING KNOT ADVANCEMENT. THE RETURNED SUTURE (APPROXIMATELY 20 INCHES) WAS CUT INTO TWO PIECES AND THE PREFORMED KNOT WAS WEDGED INTO THE DISTAL END OF THE SUTURE TRIMMER, CONSISTENT WITH THE REPORTED EVENT. THE SUTURE IN THIS CASE HAD BEEN TRIMMED AND NOT BROKEN, AS EVIDENCED BY THE CUT SUTURE LIMBS. DURING TESTING, A PROXY SUTURE AND THE RETURNED PORTIONS OF THE SUTURE WERE EACH LOADED ONTO THE RETURNED SUTURE TRIMMER BY PULLING THE THUMB KNOB PROXIMALLY (AWAY FROM THE SUTURE) WITHOUT DIFFICULTY. THE THUMB KNOT WAS THEN RELEASED, CLOSING THE SUTURE GATE AND EACH (THE RETURNED PORTION AND PROXY SUTURE) SLID THROUGH THE TRIMMER WITHOUT RESISTANCE. THE SUTURE TRIMMER LEVER WAS ACTIVATED AND EACH SUTURE WAS CUT WITHOUT DIFFICULTY. DURING TESTING, THE SUTURE TRIMMER/KNOT PUSHER OPERATED NORMALLY. THE RETURN OF THE PREFORMED KNOT WITH TISSUE CAPTURED IN THE KNOT INDICATES THE KNOT PUSHER HAD INADVERTENTLY BEEN PUSHED OVER THE PREFORMED KNOT DURING ADVANCEMENT, AND REMOVED WITH THE TRIMMER AFTER THE SUTURE LIMBS HAD BEEN TRIMMED (CUT). ALTHOUGH NOT REPORTED THIS WOULD HAVE CREATED SOME RESISTANCE. EACH SUTURE TRIMMER/KNOT PUSHER IS INSPECTED DURING MANUFACTURING TO ASSURE THEY PERFORM ACCORDING TO SPECIFICATIONS. IT SHOULD BE NOTED THAT THE INSTRUCTION FOR USE (IFU) STATES: WITH THE RAIL (BLUE) SUTURE LIMB SECURELY WRAPPED AROUND YOUR LEFT FOREFINGER, PLACE NON-RAIL (WHITE) SUTURE LIMB BETWEEN YOUR LEFT THUMB AND LEFT FOREFINGER. PLACE BOTH SUTURES INTO THE SUTURE TRIMMER BY RETRACTING THE THUMB KNOB ON THE HANDLE AND USING BOW-STRING TECHNIQUE, LOAD THE SUTURE INTO THE WINDOW LOCATED AT THE DISTAL END OF THE SUTURE TRIMMER. RELEASE THE THUMB KNOB TO LOAD THE SUTURE. THE SUTURE TRIMMER SHOULD SLIDE EASILY ON THE SUTURE. ADVANCE THE KNOT. WITH THE RAIL (BLUE) SUTURE LIMB SECURELY WRAPPED AROUND THE LEFT FOREFINGER, RELEASE THE NON-RAIL (WHITE) SUTURE LIMB AND PLACE THE SUTURE TRIMMER UNDER THE LEFT THUMB TO ASSUME A SINGLE-HANDED POSITION AND COMPLETE KNOT ADVANCEMENT. WITH THE SUTURE TRIMMER IN PLACE, TIGHTEN THE KNOT BY GENTLY PULLING THE NON-RAIL (WHITE) SUTURE LIMB. HEMOSTASIS OF THE ACCESS SITE IS ACHIEVED WHEN THE KNOT IS FULLY ADVANCED TO THE ARTERIAL SURFACE, THE SLACK IS GENTLY PULLED FROM THE KNOT WITH THE NON-RAIL LIMB WHILE THE SUTURE TRIMMER HOLDS TENSION ON THE RAIL LIMB OF THE SUTURE, AND THE TISSUE IS IN COMPLETE APPOSITION. ONCE HEMOSTASIS IS ACHIEVED, USE THE SUTURE TRIMMER TO TRIM THE SUTURES BELOW THE SKIN. WHILE HOLDING CONSTANT BACK TENSION ON THE SUTURE LIMBS, LOAD BOTH LIMBS INTO THE SUTURE TRIMMER AND ADVANCE TO THE ARTERIOTOMY. TRIM THE SUTURES BY PULLING BACK ON THE RED TRIMMING LEVER. KEEP THE TRIMMING LEVER PULLED BACK DURING RETRIEVAL OF THE SUTURE TRIMMER AND TRIMMED SUTURE FROM THE TISSUE TRACT. IF ONLY ONE SUTURE LIMB HAS BEEN LOADED AND TRIMMED, REPEAT THE SAME TECHNIQUE ON THE OTHER SUTURE LIMB. BASED ON THE INVESTIGATION, THE CAUSE FOR THE REPORTED OF THE SUTURE BREAK CANNOT BE CONFIRMED. THE SUTURE IN THIS CASE HAD BEEN CUT OR TRIMMED. THE CAUSE OF THE PREFORMED KNOT BEING RETURNED WEDGED IN THE DISTAL END OF THE SUTURE TRIMMER APPEARS TO BE RELATED TO THE OPERATOR TECHNIQUE DURING USE AND NOT A PRODUCT QUALITY DEFICIENCY. 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 IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING AND 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN ATTEMPTING TO PULL THE SUTURE WITH THE SUTURE TRIMMER, THE SUTURE BROKE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE 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 040396H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention