BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2210925 · Received August 12, 2011

    Report

    Report Number
    2024168-2011-05723
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 18, 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
    CO, 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND BOTH CUFFS REMAINING IN THE FOOT POCKETS (BILATERAL CUFF MISS). THE PLUNGER AND ANTERIOR NEEDLE WERE NOT RETURNED. THERE WERE NO NEEDLE STRIKE MARKS OBSERVED AT THE ANTERIOR AND POSTERIOR FOOT TO SUGGEST THAT THE NEEDLES MIGHT HAVE BEEN DEFLECTED AND STRUCK THE FOOT INSTEAD OF ENGAGING WITH THE CUFFS INSIDE THE FOOT POCKETS DURING THE NEEDLE PLUNGER DEPLOYMENT AS INTENDED. BECAUSE BOTH CUFFS WERE STILL IN THE POCKETS, RETRACTING THE NEEDLE PLUNGER WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE, WHICH COULD APPEAR VERY SIMILAR TO THE REPORTED SUTURE BREAK. HOWEVER, THE SUTURE WAS RETURNED INTACT OUTSIDE THE DEVICE. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. DURING TESTING, THE PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. CONTRIBUTING FACTORS FOR THE BILATERAL CUFF MISS INCLUDE, BUT ARE NOT LIMITED TO: MANUFACTURING, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED WHICH COULD HAVE CONTRIBUTED TO BOTH NEEDLES BEING DEFLECTED DURING THE NEEDLE PLUNGER DEPLOYMENT AND RESULTED IN THE BILATERAL CUFF MISS. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE NEEDLE PLUNGER MIGHT HAVE BEEN PULLED OUT OF THE DEVICE PRIOR TO BEING DEPRESSED TO DEPLOY THE NEEDLES, WHICH WOULD HAVE RESULTED IN THE BILATERAL CUFF MISS. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE BILATERAL CUFF MISS COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELEVANT NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT REVEALED NO SIMILAR INCIDENTS AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED DURING MANUFACTURING. SIX UNUSED STERILE PROGLIDE DEVICES WITH THE SAME LOT NUMBER, 040356H, AS THE COMPLAINT DEVICE WERE RETURNED FOR EVALUATION. ALL RETURNED DEVICES WERE FUNCTIONALLY TESTED AND THE RESULTS MET THE MANUFACTURING CRITERIA. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A CAUSE FOR THE COMPLAINT DEVICE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY (RCFA) AFTER A DIAGNOSTIC PROCEDURE USING A PROGLIDE DEVICE. REPORTEDLY, WHEN THE PLUNGER WAS RETRACTED FROM THE DEVICE BODY, A SUTURE BREAK OCCURRED. THE DEVICE WAS REMOVED FROM THE PATIENT'S GROIN AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 040356H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention