BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2250947 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06345
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 31, 2011
    Report Date
    August 31, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 AND THE POSTERIOR NEEDLE WAS UNDISTURBED. THIS IS CONSISTENT WITH THE POSTERIOR NEEDLE BEING DEFLECTED AWAY FROM 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. THIS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE NEEDLE TIP AS EVIDENCED BY THE DAMAGED ANTERIOR CUFF TABS. THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE. AS THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. POSSIBLE CONTRIBUTING FACTORS FOR THE NEEDLE DEFLECTION THAT RESULTED IN A POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, CHALLENGING ANATOMICAL CONDITIONS AND INCORRECT DEPLOYMENT TECHNIQUES. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED DURING MANUFACTURING. DURING TESTING, THE PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. THERE WERE NO REPORTED CHALLENGING ANATOMICAL CONDITIONS SUCH AS CALCIFICATION, TORTUOSITY, OR SCARRING. THERE WAS NO REPORTED INFORMATION OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE DEVICE TO SUGGEST THAT THE DEVICE WAS TWISTED, 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 IN THE LAB AND DURING THE MANUFACTURING, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP 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. THE PROBABLE CAUSE FOR THE DETECTED POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. 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 DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INVESTIGATION, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A 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 AND ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE 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 060496H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention SHEATH: 6F