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

Model Number	M001508110
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6)2024.It was reported that the tip of the guide wire was tortuous.The target lesion was located in the celiac artery.A fathom -14 guidewire was selected for use in a celiac arteriography.During the procedure, the tip of the guide wire was tortuous, and the introduction could not be performed normally.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.However, device analysis revealed polymer jacket detached/peeled.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The guidewire was returned, and it was observed that it was detached/peeled at polymer jacket and bent at distal tip.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 27dec2024.It was reported that the tip of the guide wire was tortuous.The target lesion was located in the celiac artery.A fathom -14 guidewire was selected for use in a celiac arteriography.During the procedure, the tip of the guide wire was tortuous, and the introduction could not be performed normally.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.It was further reported that the guidewire and microcatheter were flushed with saline.When advanced into the catheter, it felt stuck, resulting in tip tortuosity.However, device analysis revealed polymer jacket detached/peeled.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information device evaluated by mfr: the device was returned for evaluation.The guidewire was returned, and it was observed that it was detached/peeled at polymer jacket and bent at distal tip.No other issues were identified during the product analysis.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6128757234
• MDR Report Key: 21200803
• Report Number: 2124215-2024-83693
• Device Sequence Number: 7560047
• Product Code: DQX
• UDI-Device Identifier: 08714729801030
• UDI-Public: 08714729801030
• 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
• Report Date (Section B): 02/06/2025

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: 0034098381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 01/12/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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: 64 YR
• Patient Sex: Male