BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II CATHETER

    MDR report key: 1589424 · Received January 8, 2010

    Report

    Report Number
    1318694-2009-00008
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    November 24, 2009
    Report Date
    December 31, 2009
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS BEING USED OFF LABEL FOR AN UNAPPROVED INDICATION. THIS DEVICE IS LABELED AND 510(K) CLEARED FOR A PTV INDICATION. THE PHYSICIAN ALSO STATED THAT THEY HAND INFLATED THE BALLOON. THE INSTRUCTIONS FOR USE STATES TO USE A INFLATION DEVICE WITH PRESSURE GAUGE WHEN INFLATING THE BALLOON. THIS WILL ENSURE THAT THE RBP IS NOT EXCEEDED.

    Description of Event or Problem · 1

    CATHETER BALLOON BURST WHILE TRYING TO INFLATE A GENESIS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK II CATHETER PTV CATHETER LIT NUMED, INC. 105 TT-6019

    Patients

    Seq Age Sex Outcome Treatment
    1