BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2193240 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05555
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INSPECTION OF THE RETURNED DEVICE REVEALED THAT A POSTERIOR CUFF MISS OCCURRED DURING THE NEEDLE DEPLOYMENT AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. THERE WAS NO NEEDLE STRIKE MARK OBSERVED AT THE POSTERIOR FOOT, SUGGESTING THAT THE POSTERIOR NEEDLE WAS DEFLECTED AWAY FROM THE POSTERIOR FOOT DURING NEEDLE DEPLOYMENT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET AS INTENDED. BECAUSE THE POSTERIOR NEEDLE DID NOT ENGAGE WITH THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER, RESULTING IN THE LINK DETACHING FROM THE SWAGE END OF THE ANTERIOR CUFF. THE POSTERIOR CUFF MISS AND SUBSEQUENT LINK DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE. CONTRIBUTING FACTORS FOR NEEDLE DEFLECTION THAT RESULTED IN THE POSTERIOR CUFF MISS AND SUBSEQUENT LINK DETACHMENT INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND/OR INCORRECT DEPLOYMENT TECHNIQUE. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED DURING MANUFACTURING. DURING TESTING, THE PLUNGER WAS REINSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. ALTHOUGH, NO CALCIFICATION WAS REPORTED, THE REPORTED PRIOR ARTERIOTOMY IN THE TARGET GROIN COULD HAVE CONTRIBUTED TO THE DETECTED CUFF MISS, BUT THIS COULD NOT BE CONFIRMED. BASED ON THE SUCCESSFUL TEST OF THE NEEDLE TRAJECTORY, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT LINK DETACHMENT 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. 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 FOR THIS LOT WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    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.

    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. REPORTEDLY, A CUFF MISS OCCURRED. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE. 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 040366H

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SHEATH: 6FOTHER: HEPARIN