BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE BALLOON ESOPHAGEAL

    MDR report key: 2844760 · Received November 1, 2012

    Report

    Report Number
    1037905-2012-00605
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 4, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNQ
    PMA / PMN Number
    K061937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. A VISUAL EXAMINATION OF THE BALLOON MATERIAL CONFIRMED THE PRESENCE OF A LARGE SPLIT IN THE BALLOON MATERIAL. THE SPLIT IS POSITIONED LENGTH-WISE ON THE BALLOON COMPONENT AND IS APPROXIMATELY THE SAME LENGTH OF THE BALLOON. NO SECTION OF THE BALLOON MATERIAL IS MISSING FROM THE DEVICE. 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 DISEASE STATED, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. THE REPORTER WAS UNABLE TO SPECIFY IF NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON DEVICE PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT USER TO APPLY NEGATIVE PRESSURE TO THE CATHETER TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE. 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 RUPTURE 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 FACILITATE PASSAGE THROUGH THE ENDOSCOPE ACCESSORY CHANNEL. THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. A BALLOON RUPTURE 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 DIRECT THE USER TO ENSURE THE BALLOON IS COMPLETELY VISUALIZED AND POSITIONED BEFORE INFLATION. 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 RUPTURE OF THE BALLOON MATERIAL. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING: "DURING DILATION, DO NOT INFLATE BALLOON BEYOND THE MAXIMUM INDICATED INFLATION PRESSURE." OVER INFLATION CAN CAUSE DAMAGE TO THE BALLOON DILATOR, SUCH AS A RUPTURE OR SPLIT. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE ESOPHAGEAL BALLOON DILATORS ARE SUBJECTED TO A LEAK TEST 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: 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 THE PROCEDURE, A COOK HERCULES 3 STAGE ESOPHAGEAL BALLOON WAS USED IN THE ESOPHAGUS. THE BALLOON WAS ADVANCED INTO POSITION AND INFLATED WITH WATER. THE PHYSICIAN WAS INFLATING THE BALLOON TO 18 (MM) AND THEN UP TO 19 (MM). WHEN THE BALLOON REACHED 19 (MM) IT POPPED. THE PHYSICIAN REMOVED THE BALLOON AND USED ANOTHER OF THE SAME TYPE 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
    1 HERCULES 3 STAGE BALLOON ESOPHAGEAL KNQ, ESOPHAGEAL DILATOR KNQ WILSON-COOK MEDICAL INC W3177055

    Patients

    Seq Age Sex Outcome Treatment
    1 REQUEST COOK DS-60CC-S DILATION SYRINGE| FUJI ENDOSCOPE (UNKNOWN MODEL NUMBER)| ALLIANCE INFLATION GUN