BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYSHAK II BALLOON DILATATION CATHETER

    MDR report key: 966056 · Received December 18, 2007

    Report

    Report Number
    1318694-2007-00006
    Event Type
    Other
    Date Received
    December 18, 2007
    Date of Event
    November 6, 2007
    Report Date
    December 18, 2007
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K030589
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MFG REP CONFIRMED WITH THE USER FACILITY THAT A SNARE WAS USED TO REMOVE THE BALLOON MATERIAL. THE SNARE LOST HOLD OF THE MATERIAL BEFORE IT COULD BE EXTRACTED; UNABLE TO DETERMINE THE LOCATION AFTERWARDS. THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. ACCORDING TO NUMED INVESTIGATION RESULTS, A VISUAL EXAMINATION OF THE BALLOON SECTION WAS PERFORMED UNDER 30X MAGNIFICATION; A CIRCUMFERENTIAL BURST WAS CONFIRMED WITH BALLOON FRAGMENTATION. IN ADDITION, A NON-STERILE CATHETER FROM THE SAME LOT WAS USED FOR DESTRUCTIVE EVAL. THE TEST CATHETER WAS EASILY INTRODUCED INTO A 5F BRAUN INTRODUCER AND INFLATED IN A BODY TEMP BATH USING AN INDEFLATOR. RESULTS OF THIS EVAL SHOWED THE BALLOON BURST AS INTENDED (LONGITUDINALLY) AT 7 ATM AND WAS EASILY REMOVED FROM THE INTRODUCER. A REVIEW OF THE MFG TRAVELER PACKAGE FOR THE LOT SHOWED THAT ALL BUT 1 UNIT MET FINISHED QA ACCEPTANCE; THE 1 UNIT NOT MEETING QA ACCEPTANCE WAS REJECTED. THE CAUSE OF THE CIRCUMFERENTIAL BURST COULD NOT BE DETERMINED. PERHAPS THE BURST WAS CAUSED BY PT ANATOMY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTED EVENT AND MEDWATCH FORM: A PROCEDURE INVOLVING A TYSBAK II BALLOON CATHETER WAS PERFORMED IN A PEDIATRIC PT IN 2007 TO EXPAND THE PT'S COARCH. AS THE BALLOON WAS BEING INFLATED, IT RUPTURED, TEARING IN A CIRCUMFERENTIAL MANNER WITH EMBOLIZATION OF THE BALLOON MATERIAL IN THE LEFT FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK II BALLOON DILATATION CATHETER BALLOON DILATATION CATHETER LIT NUMED, INC. PDC507 TT5367 ST617

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention