BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2091511 · Received May 17, 2011

    Report

    Report Number
    2024168-2011-03517
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 OTHER TWO PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS PARTIALLY DEPLOYED. THE POSTERIOR CUFF WAS CAPTURED AND ATTACHED TO THE NEEDLE TIP. THE COMPLETE SUTURE HAD BEEN PULLED DISTALLY OUT OF THE DEVICE. THE ANTERIOR CUFF REMAINED IN THE FOOT POCKET WITH ITS TABS INTACT. THE LINK WAS BROKEN PROXIMAL OF THE ANTERIOR CUFF WHEN THE SUTURE WAS REMOVED FROM THE DEVICE POST PROCEDURE. DURING TESTING, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY, DEPTH AND MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. THE ANTERIOR CUFF WAS CAPTURED DURING TESTING. BASED ON THE INVESTIGATION FINDINGS, AN ANTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE ANTERIOR CUFF REMAINING IN THE FOOT POCKET. THESE FINDINGS ARE CONSISTENT WITH AND CONFIRM THE REPORTED CUFF MISS DURING USE. NO NEEDLE STRIKE MARKS WERE DETECTED AT THE ANTERIOR FOOT POCKET. THIS INDICATES THE NEEDLE WAS DEFLECTED AWAY FROM THE POCKET DURING DEPLOYMENT. BECAUSE THE NEEDLE DID NOT ENGAGE THE ANTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE SUTURE WOULD NOT BE PRESENT. A CUFF-MISS CAN BE INFLUENCED BY MANY FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYMENT IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. THE MOST PROBABLE CAUSE FOR THE ANTERIOR CUFF MISS AND SUBSEQUENT FAILURE TO ACHIEVE HEMOSTASIS IS DUE TO NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT POSSIBLY CAUSED BY INTERACTION WITH ANATOMY OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. THE CUFF MISS EXPERIENCED APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY PROBLEM. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED TO PERFORM PRE-CLOSURE PLACEMENT OF THE SUTURES IN THE RIGHT COMMON FEMORAL ARTERY PRIOR TO A ABDOMINAL AORTIC ANEURYSMECTOMY PROCEDURE (AAA). REPORTEDLY, A CUFF MISS OCCURRED WITH THREE PROGLIDE DEVICES DURING THE PRE-CLOSE. A CUT-DOWN WAS COMPLETED FOLLOWING THE AAA PROCEDURE TO CLOSE THE VESSEL. SCAR TISSUE WAS NOTICED DURING THE CUT-DOWN, BUT WAS NOT VISIBLE ON THE ANGIOGRAM. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 010136H

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention