BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2233572 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06143
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    July 28, 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
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED THAT A POSTERIOR CUFF MISS OCCURRED DURING NEEDLE DEPLOYMENT AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. THERE WAS A NEEDLE STRIKE MARK OBSERVED AT THE POSTERIOR FOOT, SUGGESTING THAT THE POSTERIOR NEEDLE WAS DEFLECTED AND STRUCK THE FOOT DURING NEEDLE DEPLOYMENT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET AS INTENDED. HOWEVER, THE POSTERIOR NEEDLE TIP REMAINED UNDAMAGED. 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 INDICATED BY DAMAGED ANTERIOR CUFF TABS. ONE OF THE ANTERIOR CUFF TABS (MEASURING APPROX. 0.01 BY 0.01 INCHES) WAS BROKEN OFF AND NOT RETURNED. THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. NO MANUFACTURING/QUALITY DEFICIENCY WAS DETECTED. POSSIBLE CONTRIBUTING FACTORS FOR NEEDLE DEFLECTION THAT RESULTED IN THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT INCLUDE, BUT ARE NOT LIMITED TO: MANUFACTURING, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUE. DURING LAB TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED, WHICH COULD HAVE CONTRIBUTED TO THE NEEDLE DEFLECTION. THERE WAS NO DEFINITIVE EVIDENCE IN THE EVALUATION OF THE DEVICE TO SUGGEST THAT THE DEVICE WAS TWISTED OR ROTATED DURING NEEDLE DEPLOYMENT OR THE NEEDLES WERE NOT DEPLOYED AT A 45 DEGREE ANGLE, WHICH COULD HAVE CONTRIBUTED TO THE NEEDLE DEFLECTION. BASED ON THE TEST RESULTS OF THE NEEDLE TRAJECTORY IN THE LAB AND DURING 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. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT REVEALED NO SIMILAR INCIDENTS AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED TWICE DURING MANUFACTURING.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY (CFA) AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY A CUFF MISS OCCURRED AND HEMOSTASIS WAS ACHIEVED USING AN UNSPECIFIED METHOD. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. A 6 FR. SHEATH WAS USED DURING VESSEL CLOSURE. INFORMATION ABOUT THE CFA AND ACCESS SITE CHARACTERISTICS WAS NOT KNOWN BY THE FACILITY REPORTER. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 060226H

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention SHEATH: 6 FR