BEUDAMED
    FDA Adverse Event Death Summary report: N

    TYSHAK II BALLOON CATHETER

    MDR report key: 1694041 · Received May 14, 2010

    Report

    Report Number
    1694041
    Event Type
    Death
    Date Received
    May 14, 2010
    Date of Event
    April 21, 2010
    Report Date
    May 3, 2010
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH SEVERE DECREASE IN LV FUNCTION AND WORSENING OF AORTIC STENOSIS WAS UNDERGOING A BALLOON AORTIC VALVULOPLASTY. THE PT WAS DEEMED NOT TO BE A CANDIDATE FOR SURGERY BASED ON AGE AND OTHER HEALTH RISK INCLUDING RENAL INSUFFICIENCY. DURING THE RAPID PACING AND BALLOON VALVULOPLASTY, THE PT BECAME UNRESPONSIVE. NEUROLOGY CONSULT WAS OBTAINED. NEUROLOGY PROMPTLY CONDUCTED AN EVAL INCLUDING GETTING A CT/CTA. THE CTA DEMONSTRATED NO SIGNS OF OCCLUSION, BUT HER EXAM WAS FELT TO BE CONSISTENT WITH BRAINSTEM INFARCT WITH RESOLUTION OF THE THROMBUS FROM HEPARIN. THE PT EXPIRED THE FOLLOWING DAY. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK II BALLOON CATHETER BALLOON CATHETER LIT B. BRAUN MEDICAL INC. TYSHAK II TT6463

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death