BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II PTV CATHETER

    MDR report key: 1082153 · Received July 25, 2008

    Report

    Report Number
    9618000-2008-00005
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 21, 2008
    Manufacturer
    NUMED CANADA, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN REPORTED TO THE DISTRIBUTOR THAT THE BALLOON BURST AT 2.0 ATM, AND A PIECE OF THE BALLOON MAY HAVE BEEN LEFT IN THE PATIENT. THEY WERE NOT ABLE TO FIND THE PART OF THE BALLOON UNDER ANGIO, SO IT IS UNKNOWN WHETHER IT IS IN THE PATIENT OR NOT. THE RBP FOR THIS CATHETER IS 2.0 ATM AND THE LABELED NOMINAL PRESSURE IS 1.5 ATM. THE CATHETER WAS RECEIVED AND VISUALLY INSPECTED. A CIRCUMFERENTIAL BALLOON BURST WAS CONFIRMED. THE INNER TUBING WAS "ACCORDIONED" AND WAS STRETCHED, AND THE DISTAL PART OF THE BALLOON WITH THE IMAGE BAND WAS MISSING. TYPICALLY, THIS OCCURS WHEN THE BURST BALLOON IS BEING REMOVED FROM THE PATIENT. NUMED STATES IN THE INSTRUCTIONS FOR USE TO REMOVE THE CATHETER, INTRODUCER, AND GUIDEWIRE TOGETHER RESISTANCE IS MET DURING REMOVAL. THIS ELIMINATES THE CATHETER BEING STRETCHED, WHICH CAUSES THE END TO BE STRETCHED TO THE POINT OF BREAKING. THERE WAS NO ADVERSE EVENT REPORTED WITH THE PATIENT. ACCORDING TO THE PHYSICIAN, THERE HAVE BEEN NO PROBLEMS WITH THE PATIENT'S SAFETY OR HEALTH. THREE CATHETERS OF THE SAME BALLOON DIAMETER WERE PULLED FROM CONTROLLED INVENTORY AND TESTED FOR RATED BURST PRESSURE. ALL OF THE CATHETERS BURST AT 4.0 ATM.

    Description of Event or Problem · 1

    BALLOON BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK II PTV CATHETER PTV CATHETER LIT NUMED CANADA, INC. 105 TH-9609

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK