BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING

    MDR report key: 3102083 · Received April 23, 2013

    Report

    Report Number
    1037905-2013-00165
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 3, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    GCA
    PMA / PMN Number
    K953951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RECEIVED AT COOK FOR EVAL ON (B)(6) 2013. OUR LAB EVAL CONFIRMED A SMALL SECTION OF THE BROKEN BALLOON MATERIAL IS MISSING. INFO REGARDING THE MISSING SECTION WAS COMMUNICATED BACK TO THE MEDICAL FACILITY. THE LOCATION OF THE MISSING SECTION IS UNK. INVESTIGATION EVAL: OUR EVAL OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE BALLOON WAS RUPTURED AND COULD NOT BE INFLATED DUE TO APPROX 4MM OF THE BALLOON MATERIAL WAS MISSING. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LAB 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 CONCLUSION: 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 PT 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 DETERMINE A CAUSE. THE INFO PROVIDED IN THE REPORT INDICATED THE BALLOON INFLATED PROPERLY PRIOR TO USE. THEREFORE, THE BALLOON WAS INTACT AND FUNCTIONING PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. A SPLIT OR RUPTURE IN THE BALLOON CAN OCCUR IF THE BALLOON MATERIAL HAS COME INTO CONTACT WITH A SHARP OBJECT, SUCH AS A SHARP STONE OR POSSIBLY A SHARP EDGE IN THE ENDOSCOPE ACCESSORY CHANNEL. PRIOR TO DISTRIBUTION, ALL TRI-EX MULTIPLE SIZE RADIOPAQUE EXTRACTION BALLOONS ARE SUBJECTED TO A VISUAL AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES AN AIR INFLATION TEST TO ENSURE PROPER BALLOON FUNCTION. 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. 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

    ON (B)(6) 2013, THE FOLLOWING INFO WAS PROVIDED TO COOK: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A COOK TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING WAS USED. THE BALLOON IS PLACED INSIDE [THE BILIARY DUCT] AND AFTER TWO STEP [SWEEPS], [THE BALLOON] GO OUT BROKEN. NO SECTION OF THE DEVICE DETACHED INSIDE THE ENDOSCOPE OR PT. THE PROCEDURE WAS FINISHED WITH A BASKET DEVICE. THIS INFO DID NOT REASONABLY SUGGEST A REPORTABLE EVENT HAD OCCURRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL 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
    173965 TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING GCA, CATHETER, BILIARY, SURGICAL GCA WILSON-COOK MEDICAL INC W3206871

    Patients

    Seq Age Sex Outcome Treatment
    1 PENTAX ENDOSCOPE (UNK MODEL NUMBER)