BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION GLO-TIP ERCP CATHETER

    MDR report key: 2928327 · Received January 18, 2013

    Report

    Report Number
    1037905-2013-00040
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    GBZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR EVAL OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE OUTER METAL BAND ADJACENT TO THE IDE PORT IS MISSING AND NOT INCLUDED IN THE RETURN. THERE ARE VISIBLE MARKS IN THE TUBING WHERE THE BAND WAS ORIGINALLY LOCATED. THERE ARE MINOR SCRATCHES VISIBLE IN THE BLACK INK OF THE CATHETER NEAR THE IDE PORT. THE OUTER DIAMETER OF THE CATHETER MEASURED WITHIN SPECS. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. 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 LAB 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 LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINED A CAUSE. PRIOR TO DISTRIBUTION, ALL FUSION GLO-TIP ERCP CATHETERS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. 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. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESSES THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A COOK FUSION GLO-TIP ERCP CATHETER WAS USED. THERE SEEMED TO HAVE BEEN NO RESISTANCE ENCOUNTERED THE ERCP WAS FINISHED. AT A LATER TIME, AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) WAS PERFORMED ON THE SAME PATIENT AND A STENT WAS PLACED. AFTER THIS PROCEDURE WAS FINISHED, THEY CONFIRMED THAT THE IDE PORT MARKER FROM THE COOK FUSION GLO-TIP ERCP CATHETER USED DURING THE PREVIOUS ERCP REMAINED INSIDE THE PATIENT¿S BODY. NO TREATMENT WAS CONDUCTED AT THAT TIME. BECAUSE THE PATIENT WAS SUPPOSED TO HAVE SURGERY AT A LATER DATE FOR AN UNRELATED REASON, THE PHYSICIAN DECIDED TO RETRIEVE THE MARKER DURING THAT OPERATION. SURGICAL RETRIEVAL WILL BE CONDUCTED AT A LATER DATE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON RECEIVING AN UPDATE ON THE PATIENT¿S STATUS WE WERE INFORMED THAT THE SURGERY HAS NOT YET BEEN CONDUCTED AND A DATE FOR THE OPERATION HAS NOT YET BEEN DETERMINED. THE PATIENT WAS CONFIRMED TO HAVE EXPERIENCED NO ADVERSE EFFECTS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27372 FUSION GLO-TIP ERCP CATHETER GBZ, CATHETER, CHOLANGIOGRAPHY GBZ WILSON-COOK MEDICAL INC. W3133367

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS (B)(4) ENDOSCOPE