BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULRA-THIN SDS BALLOON DILATATION CATHETER

    MDR report key: 1180945 · Received September 29, 2008

    Report

    Report Number
    2134265-2008-02820
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS DE-CLOTTING PROCEDURE, A CATHETER SHAFT BREAK OCCURRED. THE LESION WAS LOCATED IN A GRAFT IN AN UNSPECIFIED VESSEL. THE ULTRA THIN STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND INFLATED. THE PHYSICIAN THEN "ATTEMPTED TO DRAG THE BALLOON TO PULL THE CLOT BACK TOWARD THE SHEATH, BUT THE CATHETER BROKE". THE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS REPORTED AS SATISFACTORY. ADDITION INFORMATIONAL REGARDING THIS EVENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULRA-THIN SDS BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 0011470438

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR