BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIREXION? HI-FLO? FATHOM?-16 SYSTEM

    MDR report key: 21893692 · Received April 23, 2025

    Report

    Report Number
    2124215-2025-23957
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    March 25, 2025
    Report Date
    May 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839712
    PMA / PMN Number
    K142259
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K): K142259, K163701.

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K): K142259, K163701. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, AN ANALYSIS WAS CONCLUDED BASED ON THE RECEIVED PHOTO OF THE COMPLAINT DEVICE. ANALYSIS REVEALED A NICKEL SHAFT FRACTURE NEAR THE STRAIN RELIEF WITH THE INNER LUMEN EXPOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A VESSEL SPASM REQUIRING INTERVENTION. PATIENT WAS UNDER LOCAL ANESTHESIA. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS HEPATIC ARTERY. A DIREXION HI-FLO FATHOM, 16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON DELIVERING THE DOSE, IT WAS NOTED THAT THE NITINOL HYPOTUBE BROKE IN HALF REVEALING THE YELLOW SHEATH. UPON REMOVING THE MICROCATHETER, VESSEL SPASM OCCURRED. AN INTERVENTION WAS PERFORMED WITH NO LUCK TO OPEN BACK UP THE VESSEL. THE PROCEDURE WAS CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A VESSEL SPASM REQUIRING INTERVENTION. PATIENT WAS UNDER LOCAL ANESTHESIA. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS HEPATIC ARTERY. A DIREXION HI-FLO FATHOM - 16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON DELIVERING THE DOSE, IT WAS NOTED THAT THE NITINOL HYPOTUBE BROKE IN HALF REVEALING THE YELLOW SHEATH. UPON REMOVING THE MICROCATHETER, VESSEL SPASM OCCURRED. AN INTERVENTION WAS PERFORMED WITH NO LUCK TO OPEN BACK UP THE VESSEL. THE PROCEDURE WAS CANCELLED. IT WAS FURTHER REPORTED THE ISSUE WAS REPORTED VIA ATTACHED VOLUNTARY MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291222 DIREXION? HI-FLO? FATHOM?-16 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195740 0035281633 08714729839712

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention