MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM? -14; WIRE, GUIDE, CATHETER

Model Number	M001508100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: date of event - used the first date of the month of the aware date as no event date was provided.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tip broke off.The stenosed target lesion was located in the retroperitoneal thoracic duct.A 200 cm x 10 cm fathom -14 guidewire was selected for treatment.During the procedure, the tip of the guidewire separated and was retained within the patient.It was secured in place within the vessel, as the physician's initial plan involved embolization of the vessel with coils.The procedure was completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Changes to supplemental report.B1: added adverse event.B2: added required intervention to prevent permanent impairment/damage.B5: updated with additional information.H6: impact code updated.B2: date of event - used the first date of the month of the aware date as no event date was provided.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tip broke off.The stenosed target lesion was located in the retroperitoneal thoracic duct.A 200 cm x 10 cm fathom? -14 guidewire was selected for treatment.During the procedure, the tip of the guidewire separated and was retained within the patient.It was secured in place within the vessel, as the physician's initial plan involved embolization of the vessel with coils.The procedure was completed.There were no patient complications as a result of this event.It was subsequently reported that the device involved was not part of a coil but a fathom wire.The wire tip remains in the patient.The physician expressed no concerns and indicated that no monitoring is planned.The event occurred in the retroperitoneum thoracic duct.An attempt was made to retrieve the tip using a snare.

• Brand Name: FATHOM? -14
• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22515972
• Report Number: 2124215-2025-45311
• Device Sequence Number: 15591210
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: (01)08714729801023
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K111498
• 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): 08/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001508100
• Device Catalogue Number: M001508100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/26/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown