BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTIUM TTC BILIARY BALLOON DILATOR

    MDR report key: 2060799 · Received March 10, 2011

    Report

    Report Number
    1037905-2011-00128
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 8, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR EVAL OF THE RETURNED BILIARY DILATION BALLOON CONFIRMED THE REPORT. THE BALLOON MATERIAL HAS A PINHOLE, RENDERING THE DEVICE INOPERABLE. DURING OUR EVAL THE BALLOON WAS INFLATED WITH WATER USING A QUANTUM BILIARY INFLATION DEVICE. DURING INFLATION, WE OBSERVED WATER LEAKING FROM A PINHOLE IN THE BALLOON MATERIAL NEAR THE PROXIMAL END. NO PORTION OF THE BALLOON MATERIAL IS MISSING. NO OTHER OBSERVATIONS RELATED TO THE RETURNED PRODUCT WERE NOTED. 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 INFO PROVIDED INDICATED THE BALLOON DID NOT RECEIVE LUBRICATION AND NEGATIVE PRESSURE PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THIS IS THE MOST LIKELY CAUSE FOR THIS OBSERVATION. A POSSIBLE CONTRIBUTING FACTOR TO A SMALL HOLE IN THE BALLOON MATERIAL IS INADEQUATE LUBRICATION OF THE BALLOON WITH WATER SOLUBLE LUBRICANT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY A WATER SOLUBLE LUBRICANT TO THE BALLOON TO ALLOW EASIER PASSAGE THROUGH THE ACCESSORY CHANNEL. THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT NEGATIVE PRESSURE IS MANDATORY 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. PRIOR TO DISTRIBUTION, A PORTION OF THE LOT IS SUBJECTED TO A TEST TO ENSURE DEVICE INTEGRITY. DURING THIS TEST, THE OUTER DIAMETER VS. PRESSURE IS MEASURED/VERIFIED. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MFG PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING ENDOSCOPIC PAPILLARY DILATION THE PHYSICIAN USED A QUANTUM TTC BILIARY BALLOON DILATOR AND THE BALLOON WOULD NOT INFLATE FULLY. AN ADDITIONAL BALLOON WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTIUM TTC BILIARY BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC. W2875017

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS JF-240 ENDOSCOPE