MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM? -16; WIRE, GUIDE, CATHETER

Model Number	M001509100
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k111485, k170636.
Event or Problem Description
It was reported that guidewire removal difficulty occurred.A 180x25cm fathom? -16 was selected for use via right femoral access with a base 5f catheter positioned at the celiac artery origin.During the procedure, a non-boston scientific microcatheter was used to cannulate the hepatic artery.In attempt to reach distal hepatic branch, fathom wire became difficult to advance.Attempted reposition of microcatheter and advancing the wire again was unsuccessful.The physician tried to retrieve the wire to reform the tip shape but was unable to pull it back.After several unsuccessful attempts to remove the wire, the microcatheter and wire were pulled out together as one piece.It was then noted that the wire had started to unravel inside the microcatheter.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k111485, k170636.This is determined to be a duplicate.Based on feedback, the original complaint had already been reported via medwatch (b)(4).
Event or Problem Description
It was reported that guidewire removal difficulty occurred.A 180x25cm fathom -16 was selected for use via right femoral access with a base 5f catheter positioned at the celiac artery origin.During the procedure, a non-boston scientific microcatheter was used to cannulate the hepatic artery.In attempt to reach distal hepatic branch, fathom wire became difficult to advance.Attempted reposition of microcatheter and advancing the wire again was unsuccessful.The physician tried to retrieve the wire to reform the tip shape but was unable to pull it back.After several unsuccessful attempts to remove the wire, the microcatheter and wire were pulled out together as one piece.It was then noted that the wire had started to unravel inside the microcatheter.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Based on the additional information received, it was determined that the complaint had been reported via medwatch 0300640000-2025-8009, and not via medwatch 0300640000-2025-8011 as previously reported.Also, b5 has been updated to include additional information about arterial access based on the medwatch form.G4 - premarket / 510(k) #: k111485, k170636.
Event or Problem Description
It was reported that guidewire removal difficulty occurred.A 180x25cm fathom -16 was selected for use via right femoral access with a base 5f catheter positioned at the celiac artery origin.During the procedure, a non-boston scientific microcatheter was used to cannulate the hepatic artery.In attempt to reach distal hepatic branch, fathom wire became difficult to advance.Attempted reposition of microcatheter and advancing the wire again was unsuccessful.The physician tried to retrieve the wire to reform the tip shape but was unable to pull it back.After several unsuccessful attempts to remove the wire, the microcatheter and wire were pulled out together as one piece.It was then noted that the wire had started to unravel inside the microcatheter.The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the ultrasound-guided arterial access was obtained via the right common femoral artery.
Event or Problem Description
It was reported that guidewire removal difficulty occurred.A 180x25cm fathom? -16 was selected for use via right femoral access with a base 5f catheter positioned at the celiac artery origin.During the procedure, a non-boston scientific microcatheter was used to cannulate the hepatic artery.In attempt to reach distal hepatic branch, fathom wire became difficult to advance.Attempted reposition of microcatheter and advancing the wire again was unsuccessful.The physician tried to retrieve the wire to reform the tip shape but was unable to pull it back.After several unsuccessful attempts to remove the wire, the microcatheter and wire were pulled out together as one piece.It was then noted that the wire had started to unravel inside the microcatheter.The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the ultrasound-guided arterial access was obtained via the right common femoral artery.
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k111485, k170636.Device evaluated by mfr: the fathom device was returned for analysis.Upon examination, the guidewire, returned attached to the torquer device, showed detachment and kinking at the distal tip.Microscope inspection confirmed the distal tip was detached.

• Brand Name: FATHOM? -16
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21886616
• Report Number: 2124215-2025-25130
• Device Sequence Number: 3531017
• Product Code: DQX
• UDI-Device Identifier: 08714729762553
• UDI-Public: (01)08714729762553(17)280114(10)35627349
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001509100
• Device Catalogue Number: M001509100
• Device Lot Number: 0035627349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 04/18/2025; 05/07/2025; 07/08/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/15/2025; 06/05/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER - 2.8FR PROGREAT 130CM; MICROCATHETER - 2.8FR PROGREAT 130CM; MICROCATHETER - 2.8FR PROGREAT 130CM; MICROCATHETER - 2.8FR PROGREAT 130CM
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White