BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FATHOM -16

    MDR report key: 20578515 · Received October 31, 2024

    Report

    Report Number
    2124215-2024-68198
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    October 20, 2024
    Report Date
    February 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K170636. DEVICE EVALUATED BY MFR: THE PRODUCT WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. VISUAL INSPECTION REVEALED THAT THE POLYMER JACKET AT THE DISTAL TIP WAS DETACHED/PEELED, BENT AND STRETCHED.

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K170636.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON CALCIFIED CEREBRAL ARTERY. A 180X25CM FATHOM -16 GUIDEWIRE WAS SELECTED FOR AN INTRA ARTERIAL THROMBECTOMY PROCEDURE FOR TREATMENT OF A STROKE. THE GUIDEWIRE WAS MANIPULATED TO ENTER THE VESSEL AND SUDDENLY THE DISTAL 10CM OF THE TIP BROKE AND DETACHED PRIOR TO REACHING THE TARGET VESSEL. THE BROKEN PART WAS SUCCESSFULLY REMOVED FROM THE PATIENT, IN ONE PIECE, USING A SNARE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON CALCIFIED CEREBRAL ARTERY. A 180X25CM FATHOM 16 GUIDEWIRE WAS SELECTED FOR AN INTRA ARTERIAL THROMBECTOMY PROCEDURE FOR TREATMENT OF A STROKE. THE GUIDEWIRE WAS MANIPULATED TO ENTER THE VESSEL AND SUDDENLY THE DISTAL 10CM OF THE TIP BROKE AND DETACHED PRIOR TO REACHING THE TARGET VESSEL. THE BROKEN PART WAS SUCCESSFULLY REMOVED FROM THE PATIENT, IN ONE PIECE, USING A SNARE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804637 FATHOM -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0033392368 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention