BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2231433 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06077
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE INDICATED THAT THE POSTERIOR CUFF SUCCESSFULLY CAPTURED THE NEEDLE TIP DURING NEEDLE DEPLOYMENT. HOWEVER, THE ANTERIOR CUFF WAS OUT OF THE POCKET, BUT THE TABS WERE UNDISTURBED AND THE RIM WAS BENT. THIS IS CONSISTENT WITH AN ANTERIOR CUFF MISS AS THE ANTERIOR NEEDLE WAS DEFLECTED DURING NEEDLE DEPLOYMENT AND STRUCK ON THE RIM OF THE ANTERIOR CUFF INSTEAD OF ENGAGING WITH THE ANTERIOR CUFF AS INTENDED. THEREFORE, THE REPORTED CUFF MISS IS CONFIRMED. THE ANTERIOR CUFF MISS WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING THE NEEDLE PLUNGER RETRACTION. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. THE LINK WAS FOUND CAUGHT UNDERNEATH THE ANTERIOR FOOT WHEN CLOSING THE LEVER TO RETRACT THE FOOT AND THIS WAS NOT CONSIDERED A FAILURE MODE OF THE DEVICE AS IT WAS CAUSED BY UNSUCCESSFUL SUTURE RETRIEVAL DUE TO THE ANTERIOR CUFF MISS. IF THE ANTERIOR CUFF CAPTURED THE NEEDLE AND SUTURE WERE SUCCESSFULLY RETRIEVED, THE LINK WOULD BE WITHDRAWN OUT OF THE DEVICE DURING THE NEEDLE PLUNGER RETRACTION. POSSIBLE CONTRIBUTING FACTORS FOR AN ANTERIOR CUFF MISS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES. DURING MANUFACTURING THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED AND EVERY CUFF IS INSPECTED AND TESTED FOR PROPER ASSEMBLY. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE DEVICE WAS TWISTED OR ROTATED OR THE NEEDLES WERE DEPLOYED WHEN THE DEVICE WAS NOT AT AN APPROXIMATE 45-DEGREE ANGLE, WHICH COULD HAVE CONTRIBUTED TO THE NEEDLE DEFLECTION. BASED ON THE MANUFACTURING INSPECTION CRITERIA AND SUCCESSFUL TESTING OF THE NEEDLE TRAJECTORY, THE PROBABLE CAUSE FOR THE ANTERIOR NEEDLE STRIKING THE RIM OF THE ANTERIOR CUFF, RESULTING IN ANTERIOR CUFF MISS 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 AS A RESULT OF THIS INVESTIGATION. 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 FOUND NO 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 OTHER PERCLOSE PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. 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 A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER AN INTERVENTION PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED A CUFF MISS HAD OCCURRED. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A THIRD PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH ADDITIONAL INFORMATION RECEIVED: THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE.

    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 030126H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F AND 13F