BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2240318 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06227
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. DEVICE #2 PROGLIDE IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE CUSTOMER REPORTED THAT THE PROGLIDE DEVICE WAS USED IN A CALCIFIED COMMON FEMORAL ARTERY. THE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS, THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. IN ADDITION, CALCIFICATION AT THE ACCESS SITE DURING NEEDLE PLUNGER DEPLOYMENT CAN CAUSE THE NEEDLES TO DEFLECT IMPEDING NEEDLE-TO-CUFF CAPTURE THAT WILL RESULT IN UNSUCCESSFUL SUTURE DEPLOYMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED THAT A POSTERIOR NEEDLE-TO-CUFF MISS OCCURRED DURING NEEDLE DEPLOYMENT AS EVIDENCED BY THE UNDISTURBED POSTERIOR CUFF TABS AND UNDISTURBED POSTERIOR NEEDLE TIP, INDICATING NO ENGAGEMENT BETWEEN THESE TWO COMPONENTS. THE POSTERIOR NEEDLE TIP HAD EJECTED FROM THE POSTERIOR NEEDLE SHANK BUT REMAINED UNDISTURBED, SUGGESTING THAT THE POSTERIOR NEEDLE TIP WAS DEFLECTED AWAY FROM POSTERIOR FOOT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET DURING NEEDLE DEPLOYMENT. A POSTERIOR NEEDLE-TO-CUFF MISS WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE; SUBSEQUENTLY THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. THIS WOULD RESULT IN A FAILURE TO ACHIEVE HEMOSTASIS AND REQUIRE AN ALTERNATIVE METHOD TO CLOSE THE VESSEL AS REPORTED. POSSIBLE CONTRIBUTING FACTORS FOR NEEDLE DEFLECTION THAT COULD RESULT IN A POSTERIOR NEEDLE-TO-CUFF MISS INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES. DURING LAB TESTING, THE NEEDLE PLUNGER WAS REINSERTED RESULTING IN ACCEPTABLE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL. ADDITIONALLY, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED TWICE DURING MANUFACTURING. THE REPORTED CALCIFICATION AT THE ACCESS SITE COULD HAVE CONTRIBUTED TO THE NEEDLE DEFLECTION; HOWEVER, THIS COULD NOT BE CONFIRMED. THE INSTRUCTIONS FOR USE (IFU), UNDER THE SPECIAL PATIENT POPULATIONS SECTION STATES THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. ALTHOUGH, THERE WAS NO DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE DEVICE WAS TWISTED, ROTATED, OR THE NEEDLES WERE DEPLOYED WHEN THE DEVICE WAS NOT AT APPROXIMATELY AT A 45-DEGREE ANGLE, WHICH COULD HAVE CONTRIBUTED TO NEEDLE DEFLECTION. BASED ON THE MANUFACTURING INSPECTION CRITERIA AND ACCEPTABLE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL, THE PROBABLE CAUSE FOR THE POSTERIOR NEEDLE-TO-CUFF MISS IS NEEDLE DEFLECTION DURING NEEDLE 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. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO NONCONFORMING MATERIAL REPORT ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO SIMILAR INCIDENTS. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED, TO INCLUDE SUTURE PLACEMENT, TO VERIFY THE FUNCTIONALITY OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC ANGIOGRAM, ARTERIOTOMY CLOSURE OF A CALCIFIED COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE PERCLOSE PROGLIDE DEVICE. REPORTEDLY, DURING SUTURE DEPLOYMENT, A NEEDLE-TO-CUFF MISS OCCURRED. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT ALSO RESULTED IN A NEEDLE-TO-CUFF MISS. A THIRD PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 050166H

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention