BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2250438 · Received September 15, 2011

    Report

    Report Number
    2024168-2011-06338
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 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 REVEALED THAT A POSTERIOR NEEDLE-TO-CUFF MISS OCCURRED DURING THE NEEDLE DEPLOYMENT AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE POSTERIOR FOOT POCKET. THE POSTERIOR NEEDLE TIP HAD RELEASED FROM THE NEEDLE SHANK BUT DID NOT ENGAGE WITH THE POSTERIOR CUFF AND REMAINED 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 POSTERIOR FOOT. WHEN THE NEEDLE 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 NEEDLE PLUNGER. THIS RESULTED IN THE LINK DETACHING FROM THE SWAGE END OF THE ANTERIOR CUFF AS OBSERVED. THE POSTERIOR CUFF MISS AND SUBSEQUENT LINK-TO-ANTERIOR CUFF DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE AS REPORTED. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. SUBSEQUENTLY, A FAILURE TO ACHIEVE HEMOSTASIS WOULD OCCUR THAT WOULD REQUIRE AN ALTERNATIVE METHOD TO CLOSE THE VESSEL. POSSIBLE CONTRIBUTING FACTORS FOR THE NEEDLE DEFLECTION THAT RESULTED IN A POSTERIOR NEEDLE-TO-CUFF MISS AND SUBSEQUENT LINK-TO-ANTERIOR CUFF DETACHMENT INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. DURING LAB TESTING, THE NEEDLE PLUNGER WAS REINSERTED RESULTING IN ACCEPTABLE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL. THE REPORTED MILD CALCIFICATION AT THE ACCESS SITE COULD HAVE CONTRIBUTED TO THE NEEDLES BEING DEFLECTED DURING DEPLOYMENT; HOWEVER, THIS COULD NOT BE CONFIRMED. THE INSTRUCTIONS FOR USE (IFU), UNDER THE SPECIAL PATIENT POPULATIONS SECTION, STATE 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. 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 45-DEGREE ANGLE WHICH COULD HAVE CONTRIBUTED TO THE NEEDLE DEFLECTION. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED TWICE DURING MANUFACTURING. BASED ON THE INVESTIGATION, THE PROBABLE CAUSE FOR THE POSTERIOR NEEDLE-TO-CUFF MISS THAT SUBSEQUENTLY RESULTED IN A LINK DETACHMENT AND FAILURE TO RETRIEVE THE SUTURE 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 REVEALED NO NON CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS LOT. A REVIEW OF THE COMPLAINT HANDLING DATABASE FOR LOT DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR CONTINUED BLEEDING. A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. ADDITIONALLY, EVERY CUFF IS INSPECTED AND TESTED FOR PROPER ASSEMBLY DURING MANUFACTURING. A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED, TO INCLUDE SUTURE PLACEMENT, TO VERIFY THE FUNCTIONALITY OF THE DEVICE. 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 AFTER A DIAGNOSTIC HEART CATHETERIZATION, ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE PERCLOSE PROGLIDE DEVICE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, THERE WAS NO SUTURE ATTACHED TO THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE 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 050096H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention PROCEDURAL SHEATH 6F