BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION? TRANSEND?-14 SYSTEM

    MDR report key: 23771100 · Received December 10, 2025

    Report

    Report Number
    2124215-2025-90202
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    October 15, 2025
    Report Date
    February 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839781
    PMA / PMN Number
    K142259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: K142259, K163701 REPORTED HERE AS PREMARKET / 510(K) NUMBER EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. ADDITIONAL EVENT AND PATIENT DETAILS WERE NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE EVAL BY MANUFACTURER: UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS NGMC/TRANSEND/021/BERN/1RO/155 DIREXION? TRANSEND?-14 DEVICE WAS VISUALLY EXAMINED WHICH REVEALED A NICKEL SHAFT FRACTURE LOCATED APPROXIMATELY 1.5CM FROM THE STRAIN RELIEF. THE REPORTED EVENT WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    G4: K142259, K163701 REPORTED HERE AS PREMARKET / 510(K) NUMBER EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. ADDITIONAL EVENT AND PATIENT DETAILS WERE NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE TIP DETACHED. THIS NGMC/TRANSEND/021/BERN/1RO/155 DIREXION? TRANSEND?-14 SYSTEM WAS SELECTED FOR USE. IT WAS NOTED THAT THE DEVICE DETACHED FROM THE TIP AT THE EXIT LEVEL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE TIP DETACHED. THIS NGMC/TRANSEND/021/BERN/1RO/155 DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR USE. IT WAS NOTED THAT THE DEVICE DETACHED FROM THE TIP AT THE EXIT LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108140 DIREXION? TRANSEND?-14 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195850 0036379436 08714729839781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown