BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYSHAK II BALLOON DILATATION CATHETER

    MDR report key: 978874 · Received December 19, 2007

    Report

    Report Number
    1318694-2007-00003
    Event Type
    Other
    Date Received
    December 19, 2007
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K030589
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. A CATHETER FROM CONTROLLED INVENTORY THAT HAD THE SAME BALLOON RUBING WAS PULLED FOR COMPARISON. THIS CATHETER EXCEEDED THE RATED BURST PRESSURE OF 3.5 ATM AND BURST AT 6ATM OF PRESSURE. THE PHYSICIAN STATED THAT THIS CATHETER WAS USED TO DILATE A CALCIFIED HOMOGRAFT, WHICH IS AN UNAPPROVED USE FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK II BALLOON DILATATION CATHETER BALLOON DILATATION CATHETER LIT NUMED, INC. SOC08 *

    Patients

    Seq Age Sex Outcome Treatment
    1