BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE ESOPHAGEAL BALLOON

    MDR report key: 2033701 · Received February 11, 2011

    Report

    Report Number
    1037905-2011-00057
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    WINSTON-COOK MEDICAL INC.
    Product Code
    KNQ
    PMA / PMN Number
    K061937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED FOR EVALUATION AND WE CONFIRMED ALL SECTIONS OF THE PRODUCT ARE PRESENT. THE LABEL OF THE PACKAGING INCLUDED IN THE RETURN MATCHES THE PRODUCT RETURNED. DURING A VISUAL EXAMINATION OF THE BALLOON MATERIAL, WE CONFIRMED THE PRESENCE OF IRREGULAR SHAPED PUNCTURE IN THE BALLOON MATERIAL. THE DAMAGED AREA IS LOCATED NEAR THE PROXIMAL END OF THE DILATION BALLOON AND IS NOT AT THE AREA OF THE BALLOON TO CATHETER JOINT. THE APPEARANCE OF THE DAMAGED AREA SUGGESTS THE BALLOON CAME INTO CONTACT WITH A SHARP OBJECT, PERHAPS A SHARP EDGE OF THE ENDOSCOPE USED WITH THIS BALLOON DILATOR. THE CATHETER TUBING DOES NOT EXHIBIT ANY STRETCHED OR DAMAGED AREAS. DURING A FUNCTIONAL EVALUATION, A COOK QUANTUM INFLATION DEVICE FILLED WITH WATER WAS USED IN AN ATTEMPT TO INFLATE THE BALLOON. WHEN THE BALLOON IS INFLATED WITH WATER, WATER EXITS THE BALLOON MATERIAL AT THE LOCATION OF THE DAMAGED AREA. THE BALLOON WILL NOT HOLD PRESSURE AND CANNOT PERFORM DILATION IN THIS CONDITION. A MANUFACTURING DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORT WAS NOT OBSERVED DURING OUR LABORATORY EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CONCLUSION: THE ADDITIONAL INFORMATION PROVIDED INDICATED THE BALLOONS DID NOT RECEIVE LUBRICATION PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THIS IS THE MOST LIKELY CAUSE FOR THE REPORTED OBSERVATIONS. 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. ANOTHER POSSIBLE CONTRIBUTING FACTOR TO BALLOON DAMAGE IS FAILURE TO APPLY NEGATIVE PRESSURE TO THE BALLOON DILATOR PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE 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. DAMAGE TO THE BALLOON MATERIAL 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. 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. 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 DAMAGE TO THE BALLOON MATERIAL. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE ESOPHAGEAL BALLOON DILATORS ARE SUBJECTED TO A VISUAL EXAMINATION 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 CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE ESOPHAGEAL BALLOON. THE BALLOON LEAKED ON THE LEFT SIDE, LOCATED AT THE AREA OF THE BALLOON TO CATHETER JOINT. AN ADDITIONAL BALLOON WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PATIENT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERCULES 3 STAGE ESOPHAGEAL BALLOON KNQ, ESOPHAGEAL DILATOR KNQ WINSTON-COOK MEDICAL INC. W2931956

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC INFLATION DEVICE| OLYMPUS GIF-140 ENDOSCOPE