BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER HYBRID WIRE GUIDE

    MDR report key: 3820717 · Received April 11, 2014

    Report

    Report Number
    1037905-2014-00132
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 21, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KOG
    PMA / PMN Number
    K910497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION FO THE RETURNED PRODUCT CONFIRMED THE REPORT. APPROXIMATELY 6.5CM FROM THE DISTAL END IS AN APPROXIMATELY 6.5 CM SECTION OF EXPOSED CORE WIRE. THE COATING HAS ROLLED OVER TOWARDS THE DISTAL END. APPROXIMATELY 2 CM OF THE COATING AS BEEN SPLIT AT THE PROXIMAL END OF THE EXPOSED CORE WIRE. NO PART OF THE DEVICE IS MISSING. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. A REVIEW FO THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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 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. IF ADDITIONAL PRESSURE IS APPLIED TO THE WIRE GUIDE AND/OR ACCESSORY DEVICE(S) WHILE MOVING THE WIRE GUIDE INSIDE THE ACCESSORY DEVICE(S), THIS COULD CONTRIBUTE TO WIRE GUIDE COATING DAMAGE. PRIOR TO DISTRIBUTION, ALL TRACER HYBRID WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. 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 TRACER HYBRID WIRE GUIDE. AFTER A SPHINCTEROTOMY WAS PERFORMED, THE WIRE GUIDE WAS LEFT IN PLACE AND A COOK FUSION QUATTRO EXTRACTION BALLOON (FS-QEB-A) WAS ADVANCED OVER THE WIRE GUIDE. AS THE DISTAL END OF BALLOON CATHETER EXITED THE SCOPE THE BALLOON CATHETER BEGAN TO STRIP OFF THE COATING OF THE WIRE. THE COATING ACCORDIONED DOWN THE WIRE GUIDE AND STAYED ON THE WIRE GUIDE. THE COATING DID NOT DETACH INSIDE OF THE PATIENT'S BODY. ANOTHER COOK WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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
    221619 TRACER HYBRID WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COOK FUSION OMNI-TOME SPINECTEROTOME| OLYMPUS TJF-160VF ENDOSCOPE| COOK FUSION QUATTRO EXTRACTION BALLOON (FS-QEB-A)