BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM TTC COLONIC BALLOON DILATOR

    MDR report key: 3032692 · Received March 29, 2013

    Report

    Report Number
    1037905-2013-00123
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    WILSON-COOK ENDOSCOPY
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORT. DURING THE FUNCTIONAL TEST, THE DEVICE WAS DEFLATED USING A DILATION SYRINGE AND THE ALLIANCE GUN. PER THE INSTRUCTIONS FOR USE, THE BALLOON WAS THEN INFLATED WITH WATER USING A DILATION SYRINGE AND ALLIANCE GUN. THE BALLOON WOULD ONLY REACH A PRESSURE OF 40 PSI. IT WAS THEN NOTICED THAT THERE IS A CRACK IN THE CATHETER APPROX 23 CM FROM THE PROXIMAL HUB, CAUSING THE BALLOON NOT TO HOLD PRESSURE. AN ATTEMPT TO DEPRESSURIZE THE BALLOON FAILED AS ONLY HALF OF THE WATER WAS ABLE TO BE REMOVED WITH THE INFLATION DEVICE. DURING THE VISUAL INSPECTION, IT WAS CONFIRMED THAT NO SECTION OF THE BALLOON WAS MISSING. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LAB SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. A POSSIBLE CONTRIBUTING FACTOR TO CATHETER CRACKING IS INADEQUATE LUBRICATION OF THE BALLOON WITH A 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 CATHETER 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 CATHETER PRESERVATION. PRIOR TO DISTRIBUTION, ALL QUANTUM TTC COLONIC BALLOON DILATOR ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QA 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 AN ESOPHAGEAL DILATION PROCEDURE, A COOK QUANTUM TTC COLONIC BALLOON DILATOR WAS INITIATED WITH WATER. THE BALLOON INFLATED PROPERLY, HOWEVER, WOULD NOT DEFLATE. THE PHYSICIAN MANUALLY MASSAGED THE WATER OUT OF THE BALLOON TO REMOVE FROM THE ENDOSCOPE. ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. OUR LABORATORY EVAL CONFIRMED A CRACK IN THE CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130366 QUANTUM TTC COLONIC BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK ENDOSCOPY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIF-180 ENDOSCOPE| DS-60CC-S INFLATION SYRINGE