BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOUE BALLOON CATHETER

    MDR report key: 279539 · Received May 25, 2000

    Report

    Report Number
    9614758-2000-00003
    Event Type
    Injury
    Date Received
    May 25, 2000
    Date of Event
    April 26, 2000
    Report Date
    April 29, 2000
    Manufacturer
    TORAY INDUSTRIES, INC./SETA PLANT
    Product Code
    MAD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO INITIAL REPORTER'S STATEMENT, THE PT UNDERWENT SUCCESSFUL "PTMC" ON APRIL 26, 2000. A "PTMC"-26 INOUE BALLOON CATHETER WAS USED WITH SERIAL INFLATIONS AT 22, 23 AND 23.5MM DIAMETER. UPON ATTEMPTED WITHDRAWAL OF THE SLENDERIZED BALLOON FROM THE LEFT ATRIUM A KINK AT THE DISTAL RADIOPAQUE TIP WAS NOTED MAKING WITHDRAWAL OF THE 0.025 GUIDEWIRE DIFFICULT. WITH FAIRLY VIGOROUS WITHDRAWAL THE DISTAL APPROX. 10CM OF WIRE FRACTURED AND WAS LEFT IN THE LEFT ATRIUM. THIS REQUIRED REPEAT TRANSSEPTAL PUNCTURE FROM THE LEFT FEMORAL VEIN AND THE WIRE FRAGMENT WAS SNARED INTO A MULLINS SHEATH AND REMOVED FROM THE PT. THERE WERE NO OTHER COMPLICATIONS AND THE PT DID WELL POST PROCEDURE.

    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-26 JUNE 17 1999

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention