BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUMED TYSHAK MINI PERIPHERAL BALLOON DILATATION CATHETER

    MDR report key: 5507816 · Received March 17, 2016

    Report

    Report Number
    5507816
    Event Type
    Malfunction
    Date Received
    March 17, 2016
    Date of Event
    May 5, 2015
    Report Date
    November 20, 2015
    Manufacturer
    B BRAUN INTERVENTIONAL SYSTEMS, INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN INTRODUCED THE BALLOON INTO PATIENT AND TRIED TO INFLATE. THE BALLOON WOULD NOT INFLATE AND SO WAS REMOVED ALONG WITH THE WIRE. THERE WAS ANOTHER ATTEMPT TO RE-INFLATE THE BALLOON OUTSIDE OF THE BODY AND IT REQUIRED VERY HIGH PRESSURE TO INFLATE, AND WAS VERY DIFFICULT TO DEFLATE. THEREFORE, THE BALLOON WAS SENT BACK TO THE COMPANY FOR ANALYSIS AS IT WAS NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164854 NUMED TYSHAK MINI PERIPHERAL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT B BRAUN INTERVENTIONAL SYSTEMS, INC. 611987 TYM-1313

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other