BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON CANNULATOME

    MDR report key: 3124051 · Received May 15, 2013

    Report

    Report Number
    1037905-2013-00242
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THAT THE CUTTING WIRE WAS BROKEN. DURING THE VISUAL EXAMINATION IT WAS CONFIRMED THE CUTTING WIRE HAS BROKEN AT BOTH THE PROXIMAL AND THE DISTAL ENDS, SEPARATING FROM THE DEVICE. THE BROKEN PORTION OF THE CUTTING WIRE WAS INCLUDED IN THE RETURN. A DIMENSIONAL ANALYSIS OF THE BROKEN CUTTING WIRE WAS CONDUCTED. THE DETACHED PORTION MEASURE 16.5MM. APPROXIMATELY 1.5MM OF THE CUTTING WIRE REMAINS ATTACHED AT THE PROXIMAL END OF THE CATHETER. APPROXIMATELY 7MM OF THE CUTTING WIRE IS MISSING. THE CUTTING WIRE EXHIBITS EVIDENCE OF A CAUTERY APPLICATION (BLACKENING OF THE CUTTING WIRE WAS NOTED). THE DISTAL SKIVE AREAS SHOWS EVIDENCE OF CAUTERY APPLICATION. THE CUTTING WIRE SECURING COMPONENT REMAINS INSIDE THE DISTAL END OF THE CATHETER. 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 CONCLUSIONS: 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 PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT PRODUCE 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 INSTRUCTION FOR USE CAUTION THE USER NOT TO OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE THE SPHINCTEROTOME. CUTTING WIRE BREAKAGE CAN OCCUR IF THE HANDLE IS MANIPULATED WITH THE CATHETER IN COILED POSITION OR WITH THE PRECURVED 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 PRECURVED STYLET FROM THE CANNULATING TIP. THE INSTRUCTION FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRE-CURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO SPHINCTEROTOME AND RENDER IT INOPERABLE." CUTTING WIRE BREAKAGE CAN ALSO OCCUR IF THE CUTTING WIRE MAKES CONTACT WITH THE ENDOSCOPE WHEN ELECTROSURGICAL CURRENT IS APPLIED TO PERFORM THE SPHINCTEROTOMY. THE INSTRUCTIONS FOR USE CAUTION THE USER TO ENSURE THE CUTTING WIRE IS COMPLETELY OUT OF THE ENDOSCOPE WHEN APPLYING ELECTROSURGICAL CURRENT. THE INSTRUCTIONS CAUTION THE USER THAT CONTACT OF THE CUTTING WIRE WITH THE ENDOSCOPE COULD RESULT IN BREAKAGE OF THE CUTTING WIRE. IF THE SPHINCTEROTOME IS USED WITH EXCESSIVE ELECTROSURGICAL CURRENT SETTINGS PROVIDED BY THE ELECTROSURGICAL UNIT, THIS CAN CONTRIBUTE TO CUTTING WIRE BREAKAGE. THE INSTRUCTION FOR USE FOR THIS SPHINCTEROTOME DIRECT THE USER TO VERIFY DESIRED SETTINGS BY FOLLOWING THE ELECTROSURGICAL UNIT MANUFACTURER'S INSTRUCTIONS. 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 INSTRUCTION FOR USE CAUTION THE USER THE ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING THE SPHINCTEROTOME. THE USER IS ALSO INSTRUCTED TO ADVANCE THE SPHINCTEROTOME THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE IN SHORT INCREMENTS. THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. PRIOR TO DISTRIBUTION, ALL COTTON CANNULATOME 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 · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK COTTON CANNULATOME. THE PHYSICIAN ADVANCED THE SPHINCTEROTOME OVER THE WIRE GUIDE AND THROUGH THE ENDOSCOPE ACCESSORY CHANNEL. THE CUTTING WIRE DID NOT REACT TO AN ATTEMPT TO BOW/BEND THE SPHINCTEROTOME. THEY PROCEEDED WITH THE SPHINCTEROTOMY, DURING WHICH THE CUTTING WIRE COMPLETELY BROKE OFF INSIDE THE PT. THE SEPARATED SECTION OF CUTTING WIRE WAS RETRIEVED USING RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A DEVICE MADE BY ANOTHER COMPANY. OUR EVALUATION OF THE PRODUCT CONFIRMED ONE SECTION OF THE BROKEN CUTTING WIRE WAS RETURNED. HOWEVER, ANOTHER 7MM SECTION OF THE CUTTING WIRE REMAINS MISSING AND WAS NOT INCLUDED IN THE RETURN. INFO REGARDING THE SECOND MISSING SECTION WAS COMMUNICATED BACK TO THE MEDICAL FACILITY. THE LOCATION OF THE SECOND MISSING SECTION IS UNK. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY; HOWEVER THE LOCATION OF THE SECOND MISSING SECTION IS UNK. THE PT DID NOT REQUIRE ANY ADD'L 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
    215005 COTTON CANNULATOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC W3256846

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention OLYMPUS ENDOSCOPE (UNK TYPE)| ERBE ELECTROSURGICAL UNIT| ACTIVE CORD (UNK TYPE)| WIREGUIDE: METII-35-600E