BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM TTC ESOPHAGEAL BALLOON DILATOR

    MDR report key: 2112547 · Received May 26, 2011

    Report

    Report Number
    1037905-2011-00335
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 26, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SMALL HOLE. THE HOLE IS LOCATED NEAR THE CENTER OF THE DILATION BALLOON. NO SECTION OF THE BALLOON MATERIAL IS MISSING FROM THE DEVICE. WHEN THE BALLOON IS INFLATED WITH WATER, A SMALL AND STEADY STREAM OF WATER EXITS THE BALLOON MATERIAL AT THE LOCATION OF THE SMALL HOLE. THE BALLOON WILL NOT HOLD A STEADY PRESSURE AND DILATION PERFORMANCE IS LIKELY COMPROMISED IN THIS CONDITION DUE TO THE SLOW LOSS OF PRESSURE. 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. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSION: THE REPORTER WAS UNABLE TO SPECIFY IF THE BALLOON WAS LUBRICATED PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. A POSSIBLE CONTRIBUTING FACTOR TO A HOLE IN THE BALLOON MATERIAL 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. 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. ANOTHER POSSIBLE CONTRIBUTING FACTOR TO A HOLE IN THE BALLOON MATERIAL 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. A HOLE IN 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. PRIOR TO DISTRIBUTION, ALL QUANTUM TTC 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 ESOPHAGOGASTROSCOPY, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. AFTER THE BALLOON WAS INSERTED INTO THE ESOPHAGUS AND INFLATED, IT BEGAN LOSING AIR. A SMALL HOLE WAS NOTICED IN THE BALLOON. 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 QUANTUM TTC ESOPHAGEAL BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC W2862918

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE: (UNKNOWN MODEL NUMBER)