BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM TTC ESOPHAGEAL BALLOON DILATOR

    MDR report key: 2102282 · Received April 11, 2011

    Report

    Report Number
    1037905-2011-00281
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 LARGE IRREGULAR-SHAPED PUNCTURE IN THE BALLOON MATERIAL. NO SECTION OF THE BALLOON MATERIAL IS MISSING FROM THE DEVICE. THE DAMAGED AREA IS LOCATED NEAR THE PROXIMAL END OF THE DILATION 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 IN THIS CONDITION. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. 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. 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 ADDITIONAL INFORMATION PROVIDED INDICATED THE BALLOON DILATOR DID NOT RECEIVE NEGATIVE PRESSURE PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THIS IS THE MOST LIKELY CAUSE FOR THE REPORTED OBSERVATION. 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 OPTIMIZED BALLOON PERFORMANCE. A POSSIBLE CONTRIBUTING FACTOR TO BALLOON DAMAGE 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. 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 THE 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 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

    THE BALLOON WOULD NOT INFLATE SUFFICIENTLY AND RUPTURED DURING THE PROCEDURE. ANOTHER 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 QUANTUM TTC ESOPHAGEAL BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC. W2936718

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIF2T160 GASTROSCOPE