BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYSHAK DILATATION CATHETER

    MDR report key: 287591 · Received July 27, 2000

    Report

    Report Number
    1318694-2000-00006
    Event Type
    Injury
    Date Received
    July 27, 2000
    Date of Event
    December 1, 1998
    Report Date
    July 27, 2000
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PERIPHERAL TRANSLUMINAL ANGIOPLASTY ("PTA") CATHETER WAS USED TO PERFORM AORTIC ISTHMUS STENOSIS ON A PT. THE BALLOON BURST AT AN UNSPECIFIED PRESSURE CROSSWIRE. IT IS UNKNOWN WHETHER THE BALLOON WAS INFLATED BEYOND ITS MAXIMUM RATED BURST PRESSURE. THE SURGEON WAS ABLE TO REMOVE PARTS OF DEVICE THROUGH THE CATHETER. THE OTHER PARTS WERE REMOVED SURGICALLY. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK DILATATION CATHETER PTA CATHETER LIT NUMED, INC. 102 T-0751

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention