BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH RAPIDTRANSIT 135CM W/EXT

    MDR report key: 1210610 · Received October 23, 2008

    Report

    Report Number
    1058196-2008-00252
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K972518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE REPORT WE RECEIVED FROM THE AFFILIATE INDICATED THAT AFTER A TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) PROCEDURE PERFORMED FOR TREATMENT OF LIVER CANCER, THE MICROCATHETER WAS REMOVED FROM THE PT AND THE CATHETER SHAFT FRACTURED IN TWO. THE PHYSICIAN WAS NOT CERTAIN WHICH SECTION OF THE SHAFT BROKE AND WHEN PRECISELY IT HAPPENED. THERE WAS NO DIFFICULTY DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE. THE CATHETER WAS COMPLETELY REMOVED AND THERE WAS NOTHING LEFT IN THE PT. THE PT IS IN STABLE CONDITION. THE COMPLAINT PRODUCT WAS DISCARDED IN THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. THERE IS NO INFO REGARDING THE PT AND THE TARGET VESSEL CHARACTERISTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH RAPIDTRANSIT 135CM W/EXT CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 13343291

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK