BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM? -16

    MDR report key: 22002663 · Received May 12, 2025

    Report

    Report Number
    2124215-2025-28677
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    April 14, 2025
    Report Date
    June 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K111485, K170636. DEVICE EVAL BY MANUFACTURER: UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE FATHOM-16 GUIDEWIRE WAS VISUALLY AND MICROSCOPICALLY EXAMINED, REVEALING THAT THE GUIDEWIRE WAS DETACHED, AND THE DISTAL TIP AND POLYMER JACKET WERE PEELED. THE CLINICAL OBSERVATIONS OF DISTAL TIP DETACHMENT OF DEVICE OR DEVICE COMPONENT WERE CONFIRMED.

    Additional Manufacturer Narrative · 0

    GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE PATIENT INFORMATION, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. G4: PREMARKET / 510(K) #: K111485, K170636.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT HEPATIC ARTERY. A RENEGADE HIFLO MICROCATHETER AND AN 180X25CM FATHOM-16 GUIDEWIRE WERE UTILIZED FOR A Y90 MAPPING ANGIOGRAM. A .038 NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER WAS SELECTED INTO THE CELIAC ARTERY AND THE RENEGADE HIFLO MICROCATHETER AND FATHOM GUIDEWIRE WERE SELECTED INTO THE LEFT HEPATIC ARTERY. DURING RETRACTION OF THE GUIDEWIRE, IT WAS OBSERVED THAT THE TIP OF THE WIRE HAD SEPARATED AND WAS LODGED IN THE DISTAL END OF THE RENEGADE HIFLO MICROCATHETER. THE RENEGADE HIFLO MICROCATHETER WAS REMOVED, WITH THE DETACHED FATHOM-16 TIP STILL INSIDE. THE PROCEDURE WAS COMPLETED WITH A NEW FATHOM 16 GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT ANATOMY LOCATION WAS LOCATED TIN THE CELIAC VEIN, SELECTING INTO HEPATIC ARTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT HEPATIC ARTERY. A RENEGADE HIFLO MICROCATHETER AND AN 180X25CM FATHOM-16 GUIDEWIRE WERE UTILIZED FOR A Y90 MAPPING ANGIOGRAM. A .038 NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER WAS SELECTED INTO THE CELIAC ARTERY AND THE RENEGADE HIFLO MICROCATHETER AND FATHOM GUIDEWIRE WERE SELECTED INTO THE LEFT HEPATIC ARTERY. DURING RETRACTION OF THE GUIDEWIRE, IT WAS OBSERVED THAT THE TIP OF THE WIRE HAD SEPARATED AND WAS LODGED IN THE DISTAL END OF THE RENEGADE HIFLO MICROCATHETER. THE RENEGADE HIFLO MICROCATHETER WAS REMOVED, WITH THE DETACHED FATHOM-16 TIP STILL INSIDE. THE PROCEDURE WAS COMPLETED WITH A NEW FATHOM 16 GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393660 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0035782375 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CATHETER: .038 SOS| CATHETER: .038 SOS