BEUDAMED
    FDA Adverse Event Death Summary report: N

    TYSHAK II

    MDR report key: 14105818 · Received April 13, 2022

    Report

    Report Number
    1318694-2022-00004
    Event Type
    Death
    Date Received
    April 13, 2022
    Date of Event
    March 19, 2022
    Report Date
    April 13, 2022
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    UDI-DI
    04046964339431
    PMA / PMN Number
    K003052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS NOT RETURNED FOR REVIEW. THE PHYSICIAN PROVIDED ADDITIONAL INFORMATION THAT STATED THAT THE PRE-EXISTING CONDITIONS CONTRIBUTED TO THE DEATH AND HE DID NOT ATTRIBUTE IT TO THE BALLOON BURST. THE CATHETER WAS BEING USED FOR AORTIC VALVULOPLASTY, WHICH IS AN OFF-LABEL USE FOR THIS CATHETER. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS NOT USED. THE PRESSURE REACHED BEFORE FAILURE IS UNKNOWN. THERE IS A WARNING IN THE INSTRUCTIONS FOR USE THAT STATES: "CAUTION: DO NOT EXCEED RBP. AN INFLATION DEVICE WITH PRESSURE GAUGE IS RECOMMENDED TO MONITOR PRESSURE. PRESSURE IN EXCESS OF THE RBP CAN CAUSE BALLOON RUPTURE AND POTENTIAL INABILITY TO WITHDRAW THE CATHETER THROUGH THE INTRODUCER SHEATH." A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO ISSUES WERE FOUND. ALL DEVICES WITHIN THE LOT MET ALL REQUIREMENTS FOR RELEASE AND DISTRIBUTION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. A REVIEW OF THE BALLOON COMPONENT LOT NUMBER SHOWS THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THE BALLOON USED ON THIS LOT OF CATHETERS. A COMPARATIVE CATHETER WAS TESTED. THIS CATHETER WAS THE SAME BALLOON DIAMETER, WAS MANUFACTURED USING THE SAME BALLOON MATERIAL, BUT HAD A DIFFERENT LOT NUMBER. THE BALLOON WAS IMMERSED IN A BODY TEMPERATURE WATER BATH AND INFLATED UNTIL IT FAILED. THE COMPARATIVE CATHETER DID NOT BURST UNTIL 3.0 ATM, WHICH IS MORE THAN THE LABELED RATED BURST PRESSURE OF 2.0 ATM, AND LABELED NOMINAL PRESSURE OF 1.5 ATM.

    Description of Event or Problem · 0

    AS REPORTED TO NUMED BY THE DISTRIBUTOR /USER FACILITY - PHYSICIAN WAS USING THE TYSHAK BALLOON DURING A PROCEDURE AND THE BALLOON RUPTURED. THIS PATIENT EXPIRED DURING THE PROCEDURE. PHYSICIAN BELIEVES THE DEATH IS UNLIKELY RELATED TO THE BALLOON RUPTURE AND ATTRIBUTABLE MORE TO THE PRE-EXISTING CONDITIONS IN THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708804 TYSHAK II PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER LIT NUMED, INC. 105 TT-16040 04046964339431

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Death