BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE

    MDR report key: 5748989 · Received June 24, 2016

    Report

    Report Number
    1037905-2016-00172
    Event Type
    Malfunction
    Date Received
    June 24, 2016
    Date of Event
    May 17, 2016
    Report Date
    June 15, 2016
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002347783
    PMA / PMN Number
    K901443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINALLY, AN EMDR WAS SUBMITTED FOR THIS REPORT ON 06/10/2016 WITH THE INCORRECT NUMBER IN MANUFACTURER REPORT. IT CAME TO OUR ATTENTION ON 06/15/2016 THAT THE INITIAL REPORT WAS SENT WITH MANUFACTURER REPORT NUMBER 1037905-2016-000172. THE CORRECT MANUFACTURER REPORT NUMBER WAS INTENDED TO BE 1037905-2016-00172 (AN EXTRA ZERO WAS SUBMITTED). PER THE FDA CESUB HELP DESK AND EMDR TEAM CSH-6265, IN ORDER TO CORRECT THE INCORRECT MANUFACTURER REPORT NUMBER, SUBMISSION 1037905-2016-000172 MUST BE DELETED WITH THE APPROVAL OF THE EMDR TEAM INSTEAD SENDING OF A FOLLOW UP REPORT WITH THE INCORRECT MANUFACTURER REPORT NUMBER. THIS INITIAL EMDR IS BEING SUBMITTED WITH THE SAME REPORTABLE INFORMATION, BUT WITH THE CORRECT MANUFACTURER REPORT NUMBER. CONCOMITANT MEDICAL PRODUCTS: BOSTON SCIENTIFIC LOCKING DEVICE, BOSTON SCIENTIFIC WALLFLEX BILIARY METAL STENT UNCOVERED, BOSTON SCIENTIFIC HURRICANE BILIARY DILATATION BALLOON. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE WIRE GUIDE SAID TO BE INVOLVED CONFIRMED THE REPORT OF COATING DAMAGE AT THE DISTAL END. NEAR THE 26 CM MARK ON THE DISTAL END, APPROXIMATELY 9.5 CM OF CORE WIRE IS EXPOSED AND THE COATING HAS PEELED BACK. THE PEELED COATING REMAINS ATTACHED TO THE WIRE GUIDE AND NO MATERIAL IS MISSING FROM THE DAMAGED AREA. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE SUBASSEMBLY DEVICE HISTORY RECORD FOR THE WIRE GUIDE SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. 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: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVALUATION. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THE INSTRUCTIONS FOR USE ADVISE THE USER THAT THE WIRE GUIDE SHOULD BE KEPT WET FOR BEST RESULTS. THE INSTRUCTIONS FOR USE DESCRIBE THE APPROPRIATE FLUSHING TECHNIQUES FOR USE OF THIS COATED WIRE GUIDE. THESE TECHNIQUES DESCRIBED INCLUDE, FLUSHING THE ENDOSCOPE ACCESSORY CHANNEL AND/OR LUMEN OF ACCESSORY DEVICE WITH STERILE WATER BEFORE WIRE GUIDE INSERTION. IF THESE FLUSHING TECHNIQUES ARE NOT FOLLOWED OR INADEQUATE FLUSHING OCCURS, THIS CAN CONTRIBUTE TO WIRE GUIDE COATING DAMAGE. PRIOR TO DISTRIBUTION, ALL D.A.S.H. PRE-LOADED WITH ACROBAT WIRE GUIDES 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 MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: 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 D.A.S.H. PRE-LOADED WITH ACROBAT WIRE GUIDE. PER THE COMPLAINT REPORTING FORM: "THE CONSULTANT GAINED ACCESS TO THE COMMON BILE DUCT BY USING THE SPHINCTEROTOME AND WIRE. ONCE HE WAS HAPPY WITH THE WIRE POSITION HE EXCHANGED THE SPHINCTEROTOME. IN ORDER TO MAINTAIN ACCESS TO THE BILE DUCT, THE DOCTOR SECURED THE WIRE ON THE LOCKING DEVICE. HE THEN ADVANCED THE BILIARY METAL STENT OVER THE WIRE TO PLACE IN THE BILE DUCT. UNFORTUNATELY THIS WASN'T POSSIBLE STRAIGHT AWAY DUE TO THE STRICTURE BEING TOO TIGHT SO HE EXCHANGED THE STENT FOR A BILIARY DILATATION BALLOON. DURING THIS EXCHANGE HE NOTICED THAT THE WIRE COATING HAD STARTED TO COME OFF WHERE IT WAS LOCKED IN THE LOCKING DEVICE. HE CONTINUED TO PLACE THE METAL STENT WITH THE DAMAGED WIRE. AFTER THE PROCEDURE IT WAS OBVIOUS THAT THE COATING HAD COME OFF THE WIRE EVEN MORE THAN JUST AT THE LOCKING DEVICE POSITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403143 D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY 10827002347783

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS 240 ENDOSCOPE