BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLOK CLIPS

    MDR report key: 9793260 · Received March 5, 2020

    Report

    Report Number
    3003898360-2020-00201
    Event Type
    Death
    Date Received
    March 5, 2020
    Date of Event
    January 8, 2020
    Report Date
    February 9, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). PER DHR THE PRODUCT HEMOLOK LOT# 73J1500675 WAS MANUFACTURED ON 10/05/2019 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 10/09/2015. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE CUSTOMER RETURNED TWO UNOPENED REPRESENTATIVE SAMPLES FOR INVESTIGATION. ONE SAMPLE WAS 544230 HEMOLOK ML CLIPS 6/CART 84/BOX AND THE OTHER SAMPLE WAS 544240 HEMOLOK L CLIPS 6/CART 84/BOX. THE ACTUAL SAMPLES WERE NOT RETURNED. THE RETURNED SAMPLES WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED SAMPLES REVEALED THAT THE CLIPS APPEAR TYPICAL. NO DEFECTS OR ANOMALIES WERE OBSERVED. REFERENCE FILE (B)(4) FOR INVESTIGATION PHOTOS. THE IFU FOR THIS PRODUCT, 00107980, WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU STATES, "THE CLIP MUST BE LATCHED TO ENSURE PROPER LIGATION OF THE VESSEL OR TISSUE. INSPECT THE LIGATION SITE AFTER APPLICATION TO ENSURE PROPER CLOSURE OF THE CLIP. HEM-O-LOK LIGATING CLIPS ARE CONTRAINDICATED FOR USE IN LIGATING THE RENAL ARTERY DURING LAPAROSCOPIC DONOR NEPHRECTOMY. IN PROCEDURES OTHER THAN LAPAROSCOPIC DONOR NEPHRECTOMY, TELEFLEX MEDICAL RECOMMENDS LIGATION OF THE RENAL ARTERY WITH MORE THAN ONE CLIP ON THE PATIENT SIDE WITH A MINIMUM DISTAL RENAL ARTERY CUFF OF 2-3MM BEYOND THE DISTAL CLIP. APPLICATION OF A SECOND CLIP ON ALL OTHER VESSELS OTHER THAN THE RENAL ARTERY SHOULD BE DICTATED BY THE SURGEON'S JUDGMENT. SECURITY OF THE CLOSURE SHOULD BE CONFIRMED AFTER LIGATION." A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE REPRESENTATIVE SAMPLES THAT WERE RETURNED. THE REPORTED COMPLAINT OF "CLIP SLIPPED OFF VESSEL" COULD NOT BE CONFIRMED BASED ON THE RETURNED SAMPLES. TWO REPRESENTATIVE SAMPLES WERE RETURNED. ONE SAMPLE WAS 544230 HEMOLOK ML CLIPS 6/CART 84/BOX AND THE OTHER SAMPLE WAS 544240 HEMOLOK L CLIPS 6/CART 84/BOX. THE ACTUAL SAMPLES WERE NOT RETURNED. THE RETURNED SAMPLES WERE REVIEWED WITH R & D ENGINEERS. FUNCTIONAL INSPECTION WAS PERFORMED ON THE RETURNED REPRESENTATIVE SAMPLES BY PERFORMING AN AXIAL PULL OF TEST IN ORDER TO TEST THE AMOUNT OF FORCE IT TAKES FOR THE CLIP TO FALL OFF OVER-STRESSED SURGICAL TUBING. PER R & D: "AXIAL PULL OFF TESTING OF THE RETURNED COMPLAINT SAMPLES VERSUS RANDOMLY SELECTED PRODUCTION CLIPS DID SHOW STATISTICALLY DIFFERENCES IN MEANS; HOWEVER, THE VARIATION OF PRODUCTION PULL-OFF IS GREATER THAN THAT SHOWN IN THE COMPLAINT SAMPLES. WITH THE WIDER VARIATION IT IS PLAUSIBLE THAT YOU WOULD OBTAIN VALUES FOUND IN THE COMPLAINT RETURNS IN NORMAL PRODUCTION. ALL GROUPS OF CLIPS EXHIBITED FAR GREATER AXIAL PULL OFF THAN AN ESTIMATED WORST CASE OF CLINICAL RELEVANCE OF 0.11 LBF. GIVEN THE WIDE DISPARITY BETWEEN THE OBSERVED AXIAL PULL OFF VALUES AND THE ESTIMATED CLINICAL RELEVANCE IT IS HIGHLY UNLIKELY THAT THE ROOT CAUSE OF THE ISSUE IS EITHER DESIGN OR PRODUCTION." SINCE THE ACTUAL SAMPLES WERE NOT RETURNED, THE COMPLAINT COULD NOT BE CONFIRMED, AND A ROOT CAUSE COULD NOT BE ESTABLISHED. NO FUNCTIONAL ISSUES WERE FOUND WITH THE RETURNED REPRESENTATIVE SAMPLES. REFERENCE FILE (B)(4) ANALYSIS MEMO FOR THE FULL ANALYSIS AND CONCLUSION OF THE AXIAL PULL OFF TEST AND FILE (B)(4) FOR INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROBOTIC RADICAL NEPHRECTOMY, RENAL VEIN AND ARTERY WERE DISSECTED. TWO HEMOLOK CLIPS APPLIED TOWARD THE PATIENT SIDE AND ONE TOWARD THE KIDNEY (ON BOTH THE ARTERY AND VEIN). ARTERY AND VEIN WERE DIVIDED. AFTER APPLYING THE HEMOLOK AND DIVIDING THE ARTERY AND VEIN THERE WAS GOOD CONTROL OF THE VESSELS BUT AFTER ABOUT 1-MINUTE MASSIVE BLEEDING OCCURRED. EXPLANATION IS SLIPPED HEMOLOK CLIP. CODE BLUE INITIATED BUT COULD NOT SAVE THE PATIENT. THE PATIENT DIED. IT IS UNKNOWN IF THE DEVICE WAS CONTRIBUTORY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT HEMOLOK LOT# 73J1500675 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROBOTIC RADICAL NEPHRECTOMY, RENAL VEIN AND ARTERY WERE DISSECTED. TWO HEMOLOK CLIPS APPLIED TOWARD THE PATIENT SIDE AND ONE TOWARD THE KIDNEY (ON BOTH THE ARTERY AND VEIN). ARTERY AND VEIN WERE DIVIDED. AFTER APPLYING THE HEMOLOK AND DIVIDING THE ARTERY AND VEIN THERE WAS GOOD CONTROL OF THE VESSELS BUT AFTER ABOUT 1-MINUTE MASSIVE BLEEDING OCCURRED. EXPLANATION IS SLIPPED HEMOLOK CLIP. CODE BLUE INITIATED BUT COULD NOT SAVE THE PATIENT. THE PATIENT DIED. IT IS UNKNOWN IF THE DEVICE WAS CONTRIBUTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256777 HEMOLOK CLIPS FZP TELEFLEX MEDICAL 73H1700253

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death| H| L| R N.A