BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM TTC BILIARY BALLOON DILATOR

    MDR report key: 3178963 · Received June 14, 2013

    Report

    Report Number
    1037905-2013-00417
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR EVAL OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE BALLOON WAS INFLATED USING A QBID INFLATION DEVICE TO THE RECOMMENDED INFLATION PRESSURE OF 6 ATM. A SMALL LEAK WAS DETECTED AT THE DISTAL TIP OF THE DEVICE, THE LEAK WAS SUCH THAT THE BALLOON INFLATION PRESSURE WAS MAINTAINED. THE LEAK IS OCCURRING IN THE AREA OF THE CATHETER WHERE THE CATHETER LUMENS ARE CLOSED VIA A TIPPING PROCESS. IT APPEARS THE TIP PROCESS WAS PERFORMED HOWEVER THE LUMENS WERE NOT FULLY CLOSED. THE LEAK IS SO SMALL IT IS UNLIKELY IT WOULD BE DETECTED DURING THE LEAK TEST OF THE FINISHED DEVICE PRIOR TO DISTRIBUTION. 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 CONCLUSIONS: THE DEVICE LEAKED AT THE DISTAL END OF THE CATHETER DUE TO A MFG ANOMALY DURING THE TIP FORMING PROCESS. PRIOR TO DISTRIBUTION, ALL QUANTUM TTC BILIARY BALLOON DILATORS 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 MFG 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.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD), A COOK QUANTUM TTC BILIARY BALLOON DILATOR WAS USED. THE BALLOON WAS ADVANCED THROUGH THE ENDOSCOPE AND INFLATED WITH CONTRAST. WHEN THE DOCTOR USED THE QBD TO EXPAND THE DUODENAL PAPILLA, THE BALLOON WORKED WELL AT THE BEGINNING. WHEN THE PRESSURE GOT TO 5ATM [APPROX 75PSI], THE BALLOON WAS LEAKING AND COULD NOT HOLD WATER. NO SECTION OF THE DEVICE DETACHED INSIDE THE ENDOSCOPE OR PT. THEY CHANGED TO ANOTHER PRODUCT TO FINISH THE PROCEDURE. 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 RPTR, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271904 QUANTUM TTC BILIARY BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC W3222966

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR QBID-1 INFLATION DEVICE| OLYMPUS TJF ENDOSCOPE