BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD WIRE GUIDE

    MDR report key: 3050231 · Received April 5, 2013

    Report

    Report Number
    1037905-2013-00133
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    WILSON - COOK MEDICAL INC.
    Product Code
    KOG
    PMA / PMN Number
    K910497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. PRIOR TO DISTRIBUTION, ALL STANDARD WIRE GUIDES ARE SUBJECTED TO A INSPECTION 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: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURENCE. 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 ENDOSCOPY PROCEDURE FOR BILIARY STENT REMOVAL, THE PHYSICIAN USED A COOK STANDARD WIRE GUIDE. DURING INSERTION INTO ANOTHER MFR'S ERCP CATHETER, THE WIRE GUIDE BROKE AT THE PART THAT WAS NOT INSIDE THE ERCP CATHETER. NO SECTION OF THE DEVICE DETACHED INSIDE THE ENDOSCOPE OR PT. THE PHYSICIAN REPLACED IT WITH ANOTHER MFR'S WIRE GUIDE TO COMPLETE THE PROCEDURE. THE PHYSICIAN PROVIDED THE FOLLOWING COMMENT: "I PUSHED THE WIRE GUIDE GENTLY BUT IT BROKE." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. 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 OCCURENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139881 STANDARD WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG WILSON - COOK MEDICAL INC. W3085753

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS JF-260 ENDOSCOPE| BOSTON SCIENTIFIC TANDEM ERCP CATHETER