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

Model Number	M001508110
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that tip of the guidewire became separated and remained unretrieved inside the patient's body.The non-stenosed target lesion was located in the moderately tortuous and non-calcified liver.A 200cm x 10cm fathom-14 guidewire was selected for transarterial chemoembolization (tace).However, during the procedure, it was noted that the tip of the guidewire became separated within the patient's blood vessel after superselection.The separated tip remained unretrieved inside the patient's body.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Event or Problem Description
It was reported that tip of the guidewire became separated and remained unretrieved inside the patient's body.The non-stenosed target lesion was located in the moderately tortuous and non-calcified liver.A 200cm x 10cm fathom-14 guidewire was selected for transarterial chemoembolization (tace).However, during the procedure, it was noted that the tip of the guidewire became separated within the patient's blood vessel after superselection.The separated tip remained unretrieved inside the patient's body.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.It was further reported that on (b)(6) 2025, after the patient underwent digital subtraction angiography (dsa) and the target blood vessel was identified, during the process of super-selecting the target blood vessel with fathom, the blood vessel cannot be super-selected due to its complex and tortuous nature.When the fathom wire was withdrawn, about 5 cm of the tip broke off.The distal part of the fathom wire was withdrawn, and about 5 cm of the tip remained in the aberrant right hepatic artery of the superior mesenteric artery.The fathom wire broke during the super-selection process and remained in the body.The patient had no obvious symptoms, and subsequent clinical observation was required.The physician has no plan to remove the tip.The patient is stable.
Additional Manufacturer Narrative
Correction to field b3: date of event from 07/02/2025 to 07/01/2025.B5.Describe event or problem: added information, based on additional information.E1 - initial reporter facility name: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).Device evaluated by mfr: the gw fathom periph device was returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, and it was observed that the distal tip was detached.This concludes the product analysis.
Event or Problem Description
It was reported that tip of the guidewire became separated and remained unretrieved inside the patient's body.The non-stenosed target lesion was located in the moderately tortuous and non-calcified liver.A 200cm x 10cm fathom-14 guidewire was selected for transarterial chemoembolization (tace).However, during the procedure, it was noted that the tip of the guidewire became separated within the patient's blood vessel after superselection.The separated tip remained unretrieved inside the patient's body.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.It was further reported that on (b)(6) 2025, after the patient underwent digital subtraction angiography (dsa) and the target blood vessel was identified, during the process of super-selecting the target blood vessel with fathom, the blood vessel cannot be super-selected due to its complex and tortuous nature.When the fathom wire was withdrawn, about 5 cm of the tip broke off.The distal part of the fathom wire was withdrawn, and about 5 cm of the tip remained in the aberrant right hepatic artery of the superior mesenteric artery.The fathom wire broke during the super-selection process and remained in the body.The patient had no obvious symptoms, and subsequent clinical observation was required.The physician has no plan to remove the tip.The patient is stable.
Additional Manufacturer Narrative
A1 - patient identifier: updated.E1 - initial reporter facility name, address, and phone: (b)(6).Device evaluated by mfr: the gw fathom periph device was returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, and it was observed that the distal tip was detached.This concludes the product analysis.
Event or Problem Description
It was reported that tip of the guidewire became separated and remained unretrieved inside the patient's body.The non-stenosed target lesion was located in the moderately tortuous and non-calcified liver.A 200cm x 10cm fathom-14 guidewire was selected for transarterial chemoembolization (tace).However, during the procedure, it was noted that the tip of the guidewire became separated within the patient's blood vessel after superselection.The separated tip remained unretrieved inside the patient's body.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.It was further reported that on (b)(6) 2025, after the patient underwent digital subtraction angiography (dsa) and the target blood vessel was identified, during the process of super-selecting the target blood vessel with fathom, the blood vessel cannot be super-selected due to its complex and tortuous nature.When the fathom wire was withdrawn, about 5 cm of the tip broke off.The distal part of the fathom wire was withdrawn, and about 5 cm of the tip remained in the aberrant right hepatic artery of the superior mesenteric artery.The fathom wire broke during the super-selection process and remained in the body.The patient had no obvious symptoms, and subsequent clinical observation was required.The physician has no plan to remove the tip.The patient is stable.

• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22591535
• Report Number: 2124215-2025-48042
• Device Sequence Number: 9052670
• Product Code: DQX
• UDI-Device Identifier: 08714729801030
• UDI-Public: (01)08714729801030(17)271106(10)35229599
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/03/2025

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: M001508110
• Device Catalogue Number: M001508110
• Device Lot Number: 0035229599
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 09/09/2025; 11/07/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/22/2025; 10/07/2025; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 78 KG