BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME

    MDR report key: 2192961 · Received July 20, 2011

    Report

    Report Number
    1037905-2011-00483
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 20, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR EVAL OF THE RETURNED DEVICE WAS CONFIRMED THE REPORT OF INCORRECT CUTTING WIRE ORIENTATION. DURING OUR LAB ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-140R). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 2:00. (APPROPRIATE ORIENTATION IS APPROXIMATELY 11:00-1:00 O'CLOCK.) THE SPHINCTEROTOME CATHETER WAS SUBJECTED TO A CLOSE VISUAL EXAMINATION AND TWISTING OF THE TUBING WAS NOT OBSERVED. THE CUTTING WIRE HAS A SLIGHT BEND 1.5CM FROM THE DISTAL END. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS OBSERVATION WAS NOT FOUND DURING OUR LAB ANALYSIS OF THE RETURNED PRODUCT. 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. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. IMPROPER CUTTING WIRE ORIENTATION AND BENDING OF THE TIP CAN OCCUR IF THE DISTAL END OF THE CATHETER IS SHAPED MANUALLY. THIS SPHINCTEROTOME CATHETER IS PRE-CURVED AND IS PROVIDED WITH A PRE-CURVED STYLET IN THE DISTAL TIP OF THE CATHETER. THIS OBVIATES THE NEED FOR MANUAL FORMATION. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT APPLY MANUAL PRESSURE TO TIP OR CUTTING WIRE OF THE SPHINCTEROTOME TO INFLUENCE ORIENTATION, AS THIS MAY RESULT IN DAMAGE TO DEVICE." OTHER FACTORS THAT CAN CONTRIBUTE TO IMPROPER CUTTING WIRE ORIENTATION INCLUDE MANIPULATING THE HANDLE WITH THE CATHETER IN A COILED POSITION OR WITH THE PRE-CURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE ADVISE THE USER TO UNCOIL AND STRAIGHTEN THE SPHINCTEROTOME UPON REMOVING THE DEVICE FROM THE PACKAGING. THE USER IS THEN INSTRUCTED TO CAREFULLY REMOVE THE PRE-CURVED STYLET FROM THE CANNULATING TIP. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRE-COILED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO SPHINCTEROTOME AND RENDER IT INOPERABLE." PRIOR TO DISTRIBUTION, ALL CANNULATOME II PRE-CURVED DOUBLE LUMEN SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS AND CAREFULLY ADVANCED THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. WHEN THE DISTAL END OF THE SPHINCTEROTOME EXITED THE ENDOSCOPE, THE CUTTING WIRE ORIENTATION WAS NOTED TO BE IN THE 3 O'CLOCK POSITION. THIS IS UNACCEPTABLE. ANOTHER SPHINCTEROTOME WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME KNS WILSON-COOK MEDICAL INC W3000841

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS TJF - 160 ENDOSCOPE