BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER HYBRID WIRE GUIDE

    MDR report key: 4390304 · Received December 30, 2014

    Report

    Report Number
    1037905-2014-00514
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    December 2, 2014
    Report Date
    December 2, 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 EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL COOK TRACER HYBRID WIRE GUIDE ARE SUBJECTED TO A VISUAL WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL COOK TRACER HYBRID WIRE GUIDE ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QA 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. THE PHYSICIAN WAS PERFORMING A DUCTAL COMMON BILE DUCT BALLOON SWEEP WITH THE DEVICE [FUSION EXTRACTION QUATTRO BALLOON (FS-QEB-A)]. WHERE THE WIRE GUIDE EXITS THE [BALLOON] CATHETER (9 CM FROM DISTAL END, IDE PORT) THE CATHETER SNAGGED THE HYDROPHILIC COATING OF THE WIRE GUIDE. IT WOULD NOT ALLOW THE CATHETER TO BE BROUGHT BACK OVER THE WIRE GUIDE AND INTO THE ENDOSCOPE. THE CATHETER WOULD ADVANCE OVER THE WIRE GUIDE BUT IT WOULD NOT RETRACT. IT [FS-QEB-A] DID NOT STRIP THE WIRE GUIDE, IT WAS JUST SNAGGED. THE BALLOON SWEEP COULD NOT BE PERFORMED WITH THIS DEVICE. THEY HAD TO PULL THE WIRE GUIDE AND BALLOON OUT TOGETHER [WIRE GUIDE ACCESS LOST] AND START AGAIN WITH A NEW BALLOON CATHETER AND WIRE GUIDE. THE IDE PORT HAS AN ABRASIVE LOOK AND TEXTURE. 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 OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858441 TRACER HYBRID WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR OLYMPUS TJF-Q180V ENDOSCOPE| (FS-QEB-A)| COOK FUSION QUATTRO EXTRACTION BALLOON -| COOK FUSION OMNI-TOME SPHINCTEROTOME (FS-OMNI)