BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 5131224 · Received October 5, 2015

    Report

    Report Number
    1318694-2015-00007
    Event Type
    Malfunction
    Date Received
    October 5, 2015
    Date of Event
    August 18, 2015
    Report Date
    October 5, 2015
    Manufacturer
    NUMED, INC.
    Product Code
    DQY
    PMA / PMN Number
    K003052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BALLOON BURST WAS CONFIRMED UPON RETURN FROM CUSTOMER. ONLY THE DISTAL 30CM OF THE CATHETER WAS RETURNED. IT APPEARS THAT THE BALLOON BURST AND THE DISTAL END OF THE BALLOON BECAME LODGED IN THE PATIENT AND THE GUIDEWIRE TUBING BROKE WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER. IT IS NOTED IN THE REPORT THAT THE PHYSICIAN DID NOT USE AN INFLATION DEVICE WITH PRESSURE GAUGE AS RECOMMENDED IN THE INSTRUCTIONS FOR USE. INSTEAD THE PHYSICIAN USED A SYRINGE TO INFLATE THE BALLOON. BY USING A SYRINGE, THE PHYSICIAN IS NOT ABLE TO MONITOR THE PRESSURE DURING INFLATION, TO SEE IF HE IS EXCEEDING THE RBP OF THE CATHETER, IT IS ALSO NOTED IN THE REPORT THAT THE PATIENT HAD SEVERE FIBROSIS WITHIN THE VALVE THAT THEY WERE TRYING TO DILATE. NUMED INVESTIGATION SHOWS THAT THE BALLOON BURST MAY HAVE BEEN CAUSED BY THE FIBROUS MATERIAL AND THE USE OF A SYRINGE FOR THE INFLATION OF THE BALLOON. A COMPARATIVE CATHETER WAS PULLED AND EVALUATED FOR RBP. IT IS THE SAME SIZE AS THE COMPLAINT CATHETER. THE RBP FOR THIS CATHETER IS 2.5 ATM. THE COMPARATIVE CATHETER WAS TAKEN UP TO 3.5 ATM BEFORE IT BURST. IT PERFORMED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    AS REPORTED TO NUMED, INC. IN THE PRODUCT INCIDENT REPORT - "THE BALLOON WAS USED TO PERFORM PULMONARY VALVE FIBROSIS TREATMENT. WHEN THE DOCTOR INFLATED THE BALLOON, THE BALLOON SUDDENLY BURST TRANSVERSELY INTO PIECES AND LEFT IN THE PATIENT'S BODY. WHEN HE REMOVED THE BALLOON OUT, HE FOUND THE MIDDLE TUBING WAS BROKEN INTO TWO SEGMENTS. THEN THE DOCTOR USED COOK BASKET FORCEPS TO GRASP THE FRAGMENTS OUT. IT TOOK THREE HOURS TO GRASP THE FRAGMENT OUT THAT CAUSED A PROLONGED SURGICAL PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659934 TYSHAK II PERCUTANEOUS TRANSLUMINAL VALULOPLASTY CATHETER DQY NUMED, INC. 105 TT-10529

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization