BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM TTC BILIARY BALLOON DILATOR

    MDR report key: 17349908 · Received July 19, 2023

    Report

    Report Number
    1037905-2023-00340
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    June 22, 2023
    Report Date
    July 19, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FGE
    UDI-DI
    10827002226576
    PMA / PMN Number
    K171223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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. INVESTIGATION CONCLUSION: IN THE REPORT IT STATES THE BALLOON WAS USED DURING A TRANSENDOSCOPIC BILE DUCT STONE REMOVAL AND WAS USED TO DILATE THE DUODENAL PAPILLA. THIS AREA IS NOT INTENDED FOR THE USE OF THIS DEVICE AND IS THE MOST LIKELY CAUSE FOR THE REPORTED OBSERVATION. THE INTENDED USE IN THE INSTRUCTIONS FOR USE STATES: "THIS DEVICE IS USED TO DILATE STRICTURES OF THE BILIARY TREE." THE ADDITIONAL INFORMATION PROVIDED INDICATED THE BALLOON DILATOR DID NOT RECEIVE NEGATIVE PRESSURE PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE INSTRUCTIONS FOR USE ADVISE THE USER TO MAINTAIN A VACUUM (NEGATIVE PRESSURE) FOR 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. THE INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING SYSTEM PREPARATION: "ATTACH THE INFLATION DEVICE TO THE WHITE INFLATION HUB. CREATE AND MAINTAIN VACUUM WITH THE INFLATION DEVICE. REMOVE THE PROTECTIVE SHEATH FROM THE BALLOON. APPLY A WATER SOLUBLE LUBRICANT TO THE BALLOON TO ALLOW EASIER PASSAGE THROUGH THE ACCESSORY CHANNEL." PRIOR TO DISTRIBUTION, ALL QUANTUM TTC BILIARY BALLOON DILATOR ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING 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 REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT BALLOON WAS USED DURING A TRANSENDOSCOPIC BILE DUCT STONE REMOVAL AND WAS USED TO DILATE THE DUODENAL PAPILLA AND ADDITIONAL INFORMATION PROVIDED INDICATED THE BALLOON DILATOR DID NOT RECEIVE NEGATIVE PRESSURE PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE, A COOK REPRESENTATIVE 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 · 0

    DURING AN ENDOSCOPIC BILE DUCT STONE REMOVAL THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. IT WAS REPORTED [THAT] A WIRE GUIDE WAS PLACED IN THE BILE DUCT AND EST [ENDOSCOPIC SPHINCTEROTOMY] WAS PERFORMED. THE QBD-10X3 WAS ADVANCED OVER THE WIRE GUIDE TO DILATE THE DUODENAL PAPILLA [ABNORMAL USE]. THE USER FOUND THAT THERE WAS LEAKAGE OF CONTRAST MEDIUM FROM THE BALLOON AND STOPPED USING IT. HE CHANGED TO SAME ANOTHER PRODUCT (LOT# UNKNOWN). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38464 QUANTUM TTC BILIARY BALLOON DILATOR FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE WILSON-COOK MEDICAL INC W4723311 10827002226576

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENDOSCOPE - OLYMPUS JF-260V