BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOUE BALLOON CATHETER

    MDR report key: 232069 · Received July 15, 1999

    Report

    Report Number
    1649869-1999-00001
    Event Type
    Injury
    Date Received
    July 15, 1999
    Date of Event
    June 16, 1999
    Report Date
    July 15, 1999
    Manufacturer
    TORAY INDUSTRIES, INC. SETA PLANT
    Product Code
    MAD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A "PTMC" PROCEDURE, WHEN THE INOUE-BALLOON CATHETER WAS INSERTED TO THE LEFT ATRIUM THE SPRING COIL AT THE TIP OF THE GUIDEWIRE WAS BROKEN AND FLOATED IN THE PATIENT. THE DOCTOR FISHED OUT THE BROKEN PORTION BY USING ANOTHER CATHETER. AFTER THE DOCTOR FISHED OUT THE BROKEN PORTION, THE CONDITION OF THE PATIENT WAS ALRIGHT. THE GUIDEWIRE APPEARED TO HAVE BEEN REUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOUE BALLOON CATHETER BALLOON VALVULOPLASTY CATHETER MAD TORAY INDUSTRIES, INC. SETA PLANT GMS-1 DEC-19-1997

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention