BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE¿ HI-FLO¿ KIT

    MDR report key: 3023189 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01745
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    June 12, 2012
    Report Date
    February 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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 PREPARATION FOR A PERCUTANEOUS TREATMENT PROCEDURE, A CATHETER BREAK OCCURRED. LESION DETAILS ARE UNKNOWN. AS THIS 135/20 RENEGADE HI FLO INFUSION CATHETER WAS BEING REMOVED FROM THE PACKAGE, IT BROKE. THE DEVICE NEVER ENTERED THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME RENEGADE DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125050 RENEGADE¿ HI-FLO¿ KIT CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001183030 15066687

    Patients

    Seq Age Sex Outcome Treatment
    1