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

Model Number	81725
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire coating broke off.A 200 cm x 10 cm fathom -14 was selected for use in a prostatic artery embolization (pae) procedure.During insertion into the non-boston scientific microcatheter, it was noted that coating of the wire broke off/detached.The device was removed from the patient, and nothing was left in the patient.The procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.However, an analysis was concluded based on the received photo of the complaint device.It was observed that the tip was stretched and kinked, also the core wire was observed detached.
Event or Problem Description
It was reported that the wire coating broke off.A 200 cm x 10 cm fathom -14 was selected for use in a prostatic artery embolization (pae) procedure.During insertion into the non-boston scientific microcatheter, it was noted that coating of the wire broke off/detached.The device was removed from the patient, and nothing was left in the patient.The procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the fathom wire was returned for analysis; however, the complete device was not returned for evaluation.Upon receipt of the guidewire, it was noted that the distal tip was bent and stretched, and the coating was detached and peeled.The customer provided a photograph of the device, which further confirmed that the tip was stretched and kinked, with visible detachment and peeling of the coating.
Event or Problem Description
It was reported that the wire coating broke off.A 200 cm x 10 cm fathom -14 was selected for use in a prostatic artery embolization (pae) procedure.During insertion into the non-boston scientific microcatheter, it was noted that coating of the wire broke off/detached.The device was removed from the patient, and nothing was left in the patient.The procedure was completed using an alternate device.No patient complications were reported.

• 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: 20620240
• Report Number: 2124215-2024-67792
• Device Sequence Number: 8792680
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: 08714729801023
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 03/28/2025

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: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0032740893
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 11/18/2024; 03/04/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/04/2024; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: 2F 130CM PROGREAT; MICROCATHETER: 2F 130CM PROGREAT; MICROCATHETER: 2F 130CM PROGREAT
• Patient Sex: Unknown