BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL PYLORIC-COLONIC

    MDR report key: 4030102 · Received July 30, 2014

    Report

    Report Number
    1037905-2014-00309
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 30, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNQ
    PMA / PMN Number
    K090183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THE BALLOON WAS EXAMINED AND THERE WAS AN APPROXIMATELY 5 CM SPLIT IN THE PROXIMAL END OF THE BALLOON. DUE TO THE CONDITION OF THE BALLOON IT COULD NOT BE TESTED. NO PART OF THE BALLOON WAS MISSING. 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 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. ACCORDING TO THE REPORT NEGATIVE PRESSURE WAS NOT APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THE INSTRUCTIONS FOR USE ADVISE THE USER THAT NEGATIVE PRESSURE IS NEEDED TO MAINTAIN BALLOON DEFLATION. THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. A POSSIBLE CONTRIBUTING FACTOR TO BALLOON MATERIAL FAILURE IS INADEQUATE LUBRICATION OF THE BALLOON WITH A LUBRICATING AGENT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY A LUBRICATING AGENT TO THE BALLOON TO ALLOW EASIER PASSAGE THROUGH THE ACCESSORY CHANNEL .THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. A BALLOON MATERIAL FAILURE CAN OCCUR IF THE BALLOON IS INFLATED PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE OR IF THE BALLOON IS INFLATED WHILE PARTIALLY OR FULLY INSIDE THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: "DO NOT PRE-INFLATE THE BALLOON." THE INSTRUCTIONS FOR USE STATE, "MAINTAIN BALLOON DEFLATION WITH NEGATIVE PRESSURE AND INTRODUCE INTO THE ACCESSORY CHANNEL OF THE ENDOSCOPE, ADVANCING IN SHORT INCREMENTS UNTIL THE DILATOR IS COMPLETELY VISUALIZED ENDOSCOPICALLY. MONITOR ENDOSCOPICALLY UNTIL THE BALLOON IS IN THE DESIRED POSITION WITHIN THE STRICTURE." THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING: DURING DILATION DO NOT INFLATE BALLOON BEYOND THE MAXIMUM INDICATED INFLATION PRESSURE, AS THIS COULD RESULT IN OVEREXTENSION OR BURSTING OF THE BALLOON. TO ACHIEVE INCREASINGLY LARGER BALLOON DIAMETERS, INCREASE PRESSURE AS INDICATED ON THE CATHETER TAG. ANOTHER POSSIBLE CONTRIBUTING FACTOR IS USING A COMPROMISED INFLATION DEVICE TO INFLATE THE BALLOON. IF THE PRESSURE READING OF THE INFLATION DEVICE IS INACCURATE, THIS COULD CONTRIBUTE TO OVER INFLATION, POSSIBLY RESULTING IN A FAILURE OF THE BALLOON MATERIAL. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIREGUIDED ESOPHAGEAL-PYLORIC-COLONIC BALLOONS 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 MANUFACTURING 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED, THE USER DID NOT APPLY NEGATIVE PRESSURE TO THE DEVICE PRIOR TO ENDOSCOPIC ADVANCEMENT. A COOK REPRESENTATIVE HAS BEEN DIRECTED T CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPY PROCEDURE TO DILATE A MALIGNANT STRICTURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE GUIDED BALLOON. WHEN THE PHYSICIAN WAS APPLYING PRESSURE TO INFLATE THE BALLOON TO 20 MM, THE BALLOON SUDDENLY BURST AND THE DILATION COULD NOT BE COMPLETED WITH THE DEVICE. NO SECTION OF THE DEVICE DETACHED AND BECAME FREE INSIDE OF THE PATIENT. ANOTHER DEVICE 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
    445737 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC. W3283691

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIF ENDOSCOPE (UNK MODEL NUMBER)| BOSTON SCIENTIFIC JAPAN ALLIANCE HANDLE