BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE FIBER BRAIDED MICROCATHETER

    MDR report key: 1873429 · Received October 19, 2010

    Report

    Report Number
    2134265-2010-04664
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K020012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COIL EMBOLIZATION TREATMENT PROCEDURE, FOREIGN MATERIAL WAS NOTED. THE LESION BEING TREATED WAS LOCATED IN THE LIVER. THIS RENEGADE MICROCATHETER WAS INSERTED INTO AN UNSPECIFIED GUIDE CATHETER. PRIOR TO ENTERING THE PATIENT, IT WAS NOTED THAT FOREIGN MATERIAL WAS PEELING FROM THE RENEGADE CATHETER. IT IS NOT KNOWN WHERE ON THE CATHETER THE FOREIGN MATERIAL WAS NOTED AND THE FOREIGN MATERIAL WAS NOT IDENTIFIABLE. THERE WERE NO SUBSTANCES INJECTED INTO THE RENEGADE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER RENEGADE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE FIBER BRAIDED MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001182520 12839307

    Patients

    Seq Age Sex Outcome Treatment
    1