BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION? TRANSEND?-14 SYSTEM

    MDR report key: 24332657 · Received February 13, 2026

    Report

    Report Number
    2124215-2026-08226
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 20, 2026
    Report Date
    April 2, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839774
    PMA / PMN Number
    K142259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6). G4: PREMARKET / 510(K): K142259, K163701. INVESTIGATION RESULTS: DEVICE EVALUATED BY MFR: THE DIREXION DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE WAS EXAMINED VISUALLY AND MICROSCOPICALLY TO REVEAL A SHAFT FRACTURE LOCATED AT THE STRAIN RELIEF AND APPROXIMATELY 4CM FROM THE STRAIN RELIEF AND AN INNER LUMEN KINK IS LOCATED APPROXIMATELY 4CM FROM THE STRAIN RELIEF. THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE LINKED TO DEVICE BUT UNABLE TO TRACE MORE SPECIFICALLY.

    Additional Manufacturer Narrative · 0

    E1: (B)(6). G4: PREMARKET / 510(K): K142259, K163701.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MICROCATHETER FRACTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE GASTRODUODENAL ARTERY. A NGMC/TRANSEND/021/BERN/1RO/130 DIREXION WAS SELECTED FOR USE. AFTER UNPACKING, IT WAS NOTED THAT THE TAIL END OF THE MICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MICROCATHETER FRACTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE GASTRODUODENAL ARTERY. A NGMC/TRANSEND/021/BERN/1RO/130 DIREXION WAS SELECTED FOR USE. AFTER UNPACKING, IT WAS NOTED THAT THE TAIL END OF THE MICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399131 DIREXION? TRANSEND?-14 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195840 0037849393 08714729839774

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male