BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II CATHETER

    MDR report key: 3256969 · Received April 2, 2013

    Report

    Report Number
    9618000-2013-00001
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 2, 2013
    Manufacturer
    NUMED CANADA, INC.
    Product Code
    OMZ
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE BALLOON RUPTURED AT 4.0 ATM. NOMINAL PRESSURE 4.5 ATM AND RATED BURST PRESSURE 6.0 ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135404 TYSHAK II CATHETER PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER OMZ NUMED CANADA, INC. 105 TH-15144

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DA