BEUDAMED
    FDA Adverse Event Death Summary report: N

    TYSHAK II CATHETER

    MDR report key: 9123111 · Received September 26, 2019

    Report

    Report Number
    1318694-2019-00019
    Event Type
    Death
    Date Received
    September 26, 2019
    Date of Event
    July 12, 2019
    Report Date
    September 26, 2019
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    UDI-DI
    04046964339202
    PMA / PMN Number
    K003052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED TO NUMED FOR REVIEW. A LONGITUDINAL TEAR WAS CONFIRMED IN THE BALLOON. THE CAUSE OF THE BALLOON BURST COULD NOT BE IDENTIFIED THROUGH MICROSCOPIC INSPECTION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO ISSUES WERE IDENTIFIED. ALL DEVICES THAT WERE DISTRIBUTED MET THE CRITERIA FOR RELEASE AND PASSED ALL INSPECTION PROCESSES AND PROCEDURES. THERE HAVE NO OTHER COMPLAINTS WITH THIS CATHETER LOT. A REVIEW OF THE BALLOON TUBING USED TO MANUFACTURE THIS DEVICE WAS ALSO PERFORMED. THERE WERE NO OTHER ASSOCIATED COMPLAINTS WITH THIS LOT OF BALLOON TUBING. TYSHAK II CATHETERS ARE LEAK TESTED IN FINAL QC AT LABELED RATED BURST PRESSURE. A COMPARATIVE DEVICE WAS PULLED AND TESTED FOR RATED BURST PRESSURE. THIS DEVICE WAS THE SAME CATALOG NUMBER AS THE COMPLAINT DEVICE, BUT A DIFFERENT LOT NUMBER. THE BALLOON WAS IMMERSED IN A BODY TEMPERATURE WATER BATH AND INFLATED IN 0.5 ATM INCREMENTS UNTIL FAILURE. THE BALLOON BURST AT 4.0 ATM, WHICH IS DOUBLE THE LABELED RATED BURST PRESSURE OF 2.0 ATM. IT WAS A LONGITUDINAL BURST. ACCORDING TO THE REPORT FROM THE HOSPITAL, THE DEVICE WAS BEING USED OFF LABEL FOR AN UNAPPROVED INDICATION; AORTIC VALVULOPLASTY. THIS CATHETER IS ONLY INDICATED FOR PULMONARY VALVULOPLASTY. THE REPORT FROM THE HOSPITAL ALSO STATES THAT THE PHYSICIAN BELIEVED THE RUPTURE TO BE CAUSED BY THE HEAVY CALCIUM ON THE PATIENT'S VALVE WHICH POKED A HOLE IN THE BALLOON. THE PATIENT CODED DURING THE PROCEDURE AND DID NOT SURVIVE. PHYSICIAN STATED THAT THE PATIENT DID NOT CODE AS A RESULT OF THE RUPTURE. IT IS UNKNOWN IF AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED TO MONITOR THE INFLATION PRESSURE DURING THE PROCEDURE AS SPECIFIED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    MEDWATCH REPORT RECEIVED FROM DISTRIBUTOR (B)(4), WHO RECEIVED IT FROM THE FDA - VALVULOPLASTY BALLOON WAS INFLATED AND THEN BURST. IT IS BELIEVED THAT THE BALLOON RUPTURED DUE TO THE HEAVY CALCIUM ON THE PATIENT'S VALVE WHICH POKED A HOLE IN THE PLASTIC OF THE BALLOON. INFORMATION FROM THE ACCOUNT THAT WAS SENT TO (B)(4) AS A FOLLOW-UP - "IT IS UNKNOWN IF AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE PATIENT CONDITION POST PROCEDURE: PATIENT CODED DURING THE PROCEDURE AND DID NOT SURVIVE. PHYSICIAN SAID THAT PATIENT DID NOT CODE AS A RESULT OF THE RUPTURE. IT WAS AORTIC. THE TYPE AND SIZE OF GUIDEWIRE USED IS UNKNOWN AND IT IS UNKNOWN IF THE SHAFT WAS KINKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916472 TYSHAK II CATHETER PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER LIT NUMED, INC. 105 TT-13460 04046964339202

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death