BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UTS PRECURVED ULTRA TAPER SPHINCTEROTOME

    MDR report key: 19527714 · Received June 13, 2024

    Report

    Report Number
    1037905-2024-00324
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 17, 2024
    Report Date
    June 13, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    UDI-DI
    00827002224902
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172665. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. THE DETACHED PORTION OF THE CUTTING WIRE HAS BEEN TAPED TO THE EXTERIOR OF THE POUCH. OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE CUTTING WIRE HAS BROKEN AND A PORTION DETACHED. DUE TO THE BREAKS IN THE CUTTING WIRE, THE SPHINCTEROTOME WILL NOT RESPOND TO HANDLE MANIPULATION AND IS NO LONGER OPERATIONAL. THE CUTTING WIRE EXHIBITS SLIGHT EVIDENCE OF A CAUTERY APPLICATION (BLACKENING OF THE CUTTING WIRE WAS NOTED AT THE PROXIMAL END OF THE CUTTING WIRE). ALL SECTIONS OF THE CUTTING WIRE ARE PRESENT. A CLEAR SUBSTANCE WAS OBSERVED WITHIN THE CATHETER. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE CUTTING WIRE IS BROKEN AN A PORTION DETACHED. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. A BROKEN CUTTING WIRE CAN OCCUR IF THE TIP OF THE DEVICE IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER: "DO NOT OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE OR CAUSE THE CUTTING WIRE TO BREAK.". CUTTING WIRE BREAKAGE CAN OCCUR IF THE ELEVATOR OF THE ENDOSCOPE REMAINS IN THE CLOSED/UP POSITION WHEN RETRACTION OF THE SPHINCTEROTOME IS ATTEMPTED AND ADDITIONAL PRESSURE IS APPLIED, THIS COULD HAVE CONTRIBUTED TO CUTTING WIRE BREAKAGE. THE INSTRUCTIONS FOR USE CAUTION THE USER WITH THE FOLLOWING COMMENT: ¿THE ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING THE SPHINCTEROTOME.¿ THE INSTRUCTIONS FOR USE ALSO INSTRUCTS THE USER WITH THE COMMENT: ¿ADVANCE THE TIP OF THE SPHINCTEROTOME INTO THE ENDOSCOPE ACCESSORY CHANNEL AND CONTINUE TO ADVANCE IN SHORT INCREMENTS UNTIL THE DEVICE IS ENDOSCOPICALLY VISIBLE.¿. PRIOR TO DISTRIBUTION, ALL UTS PRECURVED ULTRA TAPER SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES BOWING THE SPHINCTEROTOME TO ENSURE THE DISTAL END RESPONDS TO HANDLE MANIPULATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. IT WAS REPORTED THAT A SPHINCTEROTOMY WAS ATTEMPTED (PARTIALLY COMPLETED) WITH A COOK WIRE GUIDE IN THE SPHINCTEROTOME INTO THE CBD (COMMON BILE DUCT) AND THE CUTTING WIRE COMPLETELY DETACHED FROM THE SPHINCTEROTOME. IT BECAME SLIGHTLY EMBEDDED IN THE TISSUE. THE DEFECTIVE SPHINCTEROTOME WAS REMOVED LEAVING THE WIRE GUIDE, AND THEN A NEW DEVICE WAS ADVANCED. THE SECOND SPHINCTEROTOME WAS ABLE TO COMPLETE THE SPHINCTEROTOMY AND IT WAS REMOVED. THE SECOND SPHINCTEROTOME WAS REMOVED AND A SMOOTH EDGED GRASPER WAS ADVANCED DOWN THE SCOPE. IT WAS ABLE TO GRAB THE CUTTING WIRE AND BE REMOVED SUCCESSFULLY. ONCE THE CUTTING WIRE WAS REMOVED, A PLASTIC STENT WAS PLACED AND THE CASE WAS FINISHED SUCCESSFULLY. NO ADVERSE EFFECTS WERE REPORTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE CUTTING WIRE COMPLETELY DETACHED FROM THE SPHINCTEROTOME AND BECAME SLIGHTLY EMBEDDED IN THE TISSUE. A SMOOTH EDGED GRASPER WAS ADVANCED DOWN THE SCOPE TO GRAB THE WIRE FRAGMENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803320 UTS PRECURVED ULTRA TAPER SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC W4820806 00827002224902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention BOSTON SCIENTIFIC ERCP CANNULA 5-4-3 TIP.| COOK MTII-21-480 WIRE GUIDE.| ENDOSCOPE, UNKNOWN MAKE AND MODEL.| SMOOTH EDGED GRASPER, UNKNOWN MAKE OR MODEL.