BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II CATHETER

    MDR report key: 2624477 · Received June 20, 2012

    Report

    Report Number
    1318694-2012-00008
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Date of Event
    May 14, 2012
    Report Date
    June 19, 2012
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS NOT YET BEEN RETURNED TO NUMED. ONCE IT DOES ARRIVE, IT WILL BE EVALUATED. IF THE EVAL CHANGES THIS MDR, A F/U REPORT WILL BE SENT IN. THE COMPARATIVE CATHETER PERFORMED ACCORDING TO SPEC. THE LABELED RBP FOR THIS CATHETER IS 2 ATM. THE COMPARATIVE CATHETER DID NOT BURST DURING TESTING UNTIL 4 ATM. THE PHYSICIAN STATED IN THE REPORT THAT THE PT HAD TO BE RE-BALLOONED SEVERAL TIMES DUE TO THE PT'S ANATOMY.

    Description of Event or Problem · 1

    PHYSICIAN WAS BALLOONING MPA WHEN THE BALLOON RUPTURED AT LESS THAN 1 ATM. AFTER THE RUPTURE, PHYSICIAN USED A BARD ATLAS BALLOONS, HAVING TO RE-BALLOON SEVERAL TIMES DUE TO PT'S ANATOMY AND PROCEDURE TYPE. PROCEDURE COMPLETED WITH SUCCESSFUL PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK II CATHETER PTV CATHETER LIT NUMED, INC. 105 TT-7873

    Patients

    Seq Age Sex Outcome Treatment
    1