BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOUE BALLOON CATHETER

    MDR report key: 302063 · Received October 25, 2000

    Report

    Report Number
    9614758-2000-00004
    Event Type
    Injury
    Date Received
    October 25, 2000
    Date of Event
    September 22, 2000
    Report Date
    September 26, 2000
    Manufacturer
    TORAY INDUSTRIES, INC./SETA PLANT
    Product Code
    MAD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A MITRAL VALVULOPLASTY PROCEDURE WITH THE INOUE BALLOON CATHETER, THE DISTAL TIP OF THE GUIDEWIRE HAS SEPARATED INSIDE THE PT. THE DISTAL TIP OF THE GUIDEWIRE IS STUCK AND REMAINED AT THE PT'S TRICUSPID. THE DISTAL TIP OF THE GUIDEWIRE WILL BE LEFT IN THE PT FOR TWO WEEKS, AND AT THAT TIME IT WILL BE DETERMINED IF ADD'L TREATMENT IS NECESSARY. THE PT IS COMPLETELY STABLE.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED ON 09/22/00 FOR PERCUTANEOUS TRANSVENOUS MITRAL COMMISSUROTOMY. THIS WAS PERFORMED WITHOUT DIFFICULTY. UPON REMOVAL OF THE INOUE BALLOON, THE COILED DISTAL TIP OF WIRE FRAYED AND SEPARATED FROM THE CATHETER SYSTEM AND HUNG ON THE TRICUSPID APPARATUS. THE SYSTEM WAS REMOVED AND THE FRAYED WIRE REMAINED. AN ATTEMPT TO RETRIEVE THE WIRE TIP WITH 25MM SNARE WAS UNSUCCESSFUL AS THE WIRE FRACTURED JUST PROXIMAL TO THE DISTAL TIP. A SPIRAL CT REVEALED THE PRESENCE OF THE SMALL WIRE TIP WITHIN THE RIGHT ARTERIAL TRICUSPID APPARATUS. NO INTERVENTIONS WERE FELT TO BE NECESSARY AS THE WIRE APPEARED TO BE IMMOBILE ON BOTH ECHOCARDIOGRAPHIC AND CT TESTING. FLUOROSCOPIC EVAL ALSO DEMONSTRATED NO FREE MOVEMENT. THE PT WAS PLACED ON LOVENOX AN COUMADIN THERAPY, AND WAS DISCHARGED ON 09/25/00. THE PT HAD A FOLLOW UP ECHOCARDIOGRAM. TWO MONTHS LATER, PT HAD A MITRAL VALVE REPLACEMENT. THE WIRE TIP WAS REMOVED DURING THE PROCEDURE WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOUE BALLOON CATHETER BALLOON VALVULOPLASTY CATHETER MAD TORAY INDUSTRIES, INC./SETA PLANT PTMC-28 JAN.20.2000

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention