BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE¿ HI-FLO¿ FATHOM¿ KIT

    MDR report key: 2240137 · Received September 9, 2011

    Report

    Report Number
    2134265-2011-04158
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K100892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 TRANSARTERIAL CHEMOEMBOLIZATION (TACE) TREATMENT PROCEDURE, THE INFUSION CATHETER BECAME BLOCKED. THE ANATOMY LOCATION BEING TREATED WAS A MODERATELY TORTUOUS VESSEL IN THE LIVER. THE PHYSICIAN TREATED THE PATIENT WITH ANOTHER MANUFACTURER'S 300-500 MICRON EMBOLIZATION BEADS. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE BEADS BECAME JAMMED IN THE RENAGADE HI-FLO INFUSION CATHETER. THE DEVICE WAS REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE¿ HI-FLO¿ FATHOM¿ KIT RENEGADE HI-FLO FATHOM KIT KRA BOSTON SCIENTIFIC - CORK M001184540 14363464

    Patients

    Seq Age Sex Outcome Treatment
    1 DC BEADS 300-500 MICRON