BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIREXION FATHOM-16 SYSTEM

    MDR report key: 3881502 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03464
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K132947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 TIP SEPARATION OCCURRED. DURING AN EMBOLIZATION PROCEDURE OF THE GASTRODUODENAL ARTERY (GDA), THE PHYSICIAN ENTERED THE HEPATIC ARTERY AND WAS TORQUING WITH A DIREXION FATHOM-16 SYSTEM MICROCATHETER KIT. THE PHYSICIAN REALIZED HE NEEDED A DIFFERENT MICROCATHETER, SO WHILE HE WAS REMOVING THE DIREXION, HE REALIZED THE GUIDEWIRE SEPARATED AND 7CM OF IT REMAINED IN THE ARTERY. A RENEGADE HI-FLO MICROCATHETER WAS USED TO SUCCESSFULLY RETRIEVE THE FRACTURED TIP OF THE FATHOM GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357736 DIREXION FATHOM-16 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001195640

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention