BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND?

    MDR report key: 24520956 · Received March 5, 2026

    Report

    Report Number
    2124215-2026-12329
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 4, 2026
    Report Date
    April 2, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729326243
    PMA / PMN Number
    K941710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. RISK REVIEW: A REVIEW OF THE GW TRANSEND PERIPH DEVICE WAS COMPLETED AND CONFIRMED THAT THE EVENTS WERE DEFINED IN THE RISK DOCUMENTATION. TH EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS GENICULAR ARTERY. A .014/190CM GW TRANSEND PERIPH GUIDEWIRE WAS SELECTED FOR USE IN A GENICULAR ARTERY EMBOLIZATION (GAE). DURING THE PROCEDURE, THE GUIDEWIRE TIP FRACTURED, LEAVING A PORTION IN A SIDE BRANCH. THE DEVICE WAS PARTIALLY REMOVED WITHOUT RETRIEVAL ATTEMPTS FOR THE DETACHED PORTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS GENICULAR ARTERY. A .014/190CM GW TRANSEND PERIPH GUIDEWIRE WAS SELECTED FOR USE IN A GENICULAR ARTERY EMBOLIZATION (GAE). DURING THE PROCEDURE, THE GUIDEWIRE TIP FRACTURED, LEAVING A PORTION IN A SIDE BRANCH. THE DEVICE WAS PARTIALLY REMOVED WITHOUT RETRIEVAL ATTEMPTS FOR THE DETACHED PORTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583225 TRANSEND? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001468010 0036967686 08714729326243

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown