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

Model Number	M001509100
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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: 22002663
• Report Number: 2124215-2025-28677
• Device Sequence Number: 7267362
• Product Code: DQX
• UDI-Device Identifier: 08714729762553
• UDI-Public: (01)08714729762553(17)280204(10)35782375
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 0035782375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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: CATHETER: .038 SOS; CATHETER: .038 SOS
• Patient Sex: Unknown