BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM TTC ESOPHAGEAL BALLOON DILATOR

    MDR report key: 3944092 · Received May 1, 2014

    Report

    Report Number
    1037905-2014-00158
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 1, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THERE IS A SPLIT ALONG THE LENGTH OF THE BALLOON. IT WAS NOT POSSIBLE TO INFLATE THE BALLOON IN THIS CONDITION. NO PART OF THE DEVICE IS MISSING. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LAB ANALYSIS. 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. ACCORDING TO THE REPORT, LUBRICATION AND NEGATIVE PRESSURE WERE NOT APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT 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 POSSIBLE CONTRIBUTING FACTOR TO BALLOON MATERIAL FAILURE 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 BALLOON PRESERVATION. A BALLOON MATERIAL FAILURE 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 ALSO ADVISE TO MAINTAIN BALLOON DEFLATION WITH NEGATIVE PRESSURE AND TO COMPLETELY VISUALIZE THE BALLOON ENDOSCOPICALLY. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING INFO: "RECOMMENDED 100% BALLOON INFLATION PRESSURE CAN BE FOUND ON CATHETER TAG OF BALLOON DILATOR". 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 INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: 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. ADD'L COMMENTS REGARDING THIS REPORT: BASED ON THE INFO PROVIDED, A COOK REP HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR WAS USED. WHEN THE BALLOON WAS INFLATED TO JUST UNDER 3.5 ATM, THE BALLOON BURST. NO SECTION OF THE DEVICE DETACHED INSIDE THE ENDOSCOPE OR PT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REPORT 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
    262064 QUANTUM TTC ESOPHAGEAL BALLOON DILATOR KNQ: DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLIANCE II INFLATION GUN| OLYMPUS PCF-160 ENDOSCOPE