BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION TITAN DILATION BALLOON

    MDR report key: 7486107 · Received May 4, 2018

    Report

    Report Number
    1820334-2018-01214
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    March 16, 2018
    Report Date
    July 11, 2018
    Manufacturer
    COOK INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AFTER FURTHER REVIEW OF THE RECORD, IT WAS DETERMINED THAT IT SHOULD BE NOTED THAT PER THE CUSTOMER, IT WAS DIFFICULT GAINING ACCESS TO THE DILATATION SITE(COMMON BILE DUCT). CONCOMITANT MEDICAL PRODUCTS: OLYMPUS ENDOSCOPE; 025 METRO WIRE. INVESTIGATION EVALUATION: A REVIEW OF THE DOCUMENTATION, DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE LOT NUMBER WAS UNABLE TO BE PROVIDED; THUS, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. IT IS UNKNOWN IF THERE ARE ANY ADDITIONAL COMPLAINTS DERIVING FROM THE REPORTED DEVICE¿S LOT NUMBER. THERE IS NO EVIDENCE TO SUGGEST THERE IS NON-CONFORMING PRODUCT IN HOUSE OR IN THE FIELD. THE APPROPRIATE MANUFACTURING DOCUMENTS FROM THE DEVICE MASTER RECORD (DMR) PERTAINING TO THE REPORTED FAILURE MODE WERE REVIEWED, CONFIRMING THERE ARE NO NOTABLE GAPS WITHIN THE MANUFACTURING PROCESS. INSTRUCTIONS FOR USE: WARNINGS: DO NOT EXCEED THE RECOMMENDED BALLOON INFLATION PRESSURE AS LISTED ON THE PRODUCT LABEL OR CATHETER TAG OF BALLOON. DO NOT ADVANCE THE BALLOON IF RESISTANCE IS ENCOUNTERED. STOP AND ASSESS CAUSE OF RESISTANCE TO DETERMINE IF DILATION SHOULD BE RE-ATTEMPTED. SYSTEM PREPARATION: APPLY A WATER-SOLUBLE LUBRICANT TO THE BALLOON TO ALLOW EASIER PASSAGE THROUGH THE ACCESSORY CHANNEL. IF USING ZIP PORT AND PRE-POSITIONED SHORT WIRE GUIDE: INFLATE BALLOON TO SPECIFIED INFLATION PRESSURE, AS LISTED ON THE TAG ATTACHED TO THE DEVICE. NOTE: POSITION MAY BE VERIFIED USING FLUOROSCOPIC MARKERS LOCATED AT EITHER END OF THE BALLOON.¿ A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER FOR THE DEVICE WAS NOT AVAILABLE. A COMPLAINT HISTORY SEARCH WAS ALSO UNABLE TO BE PERFORMED DUE TO THE LACK OF A LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE PROPER PERSONNEL ABOUT THIS EVENT. PER QUALITY ENGINEERING RISK ASSESSMENT, THERE IS NO FURTHER ACTIONS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K040800. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TRYING TO DILATE A DISTAL BILE DUCT STRICTURE USING A FUSION TITAN DILATION BALLOON AND QUANTUM INFLATION DEVICE, THE DISTAL TIP OF THE BALLOON BROKE AND CONTRAST FLOATED INTO THE HEPATIC DUCT. THE BALLOON WAS REMOVED AND A 10FR STENT WAS PLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328952 FUSION TITAN DILATION BALLOON FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1