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

Model Number	81725
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a guidewire fracture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified pulmonary artery.A 200cm x 10cm fathom 14 guidewire was selected for use.During the procedure, the device was fractured after multiple attempts.The procedure was completed with another of the same device.There were no reported patient complications, and the patient was stable.
Event or Problem Description
It was reported that a guidewire fracture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified pulmonary artery.A 200cm x 10cm fathom 14 guidewire was selected for use.During the procedure, the device was fractured after multiple attempts.The procedure was completed with another of the same device.There were no reported patient complications, and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The device was soaked in a saline solution in order to activate the coating at the distal section.When the coating was activated, no issues were identified in the distal tip coating.The guidewire fracture cannot be confirmed, due to the lack of evidence.

• 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: 19174096
• Report Number: 2124215-2024-23718
• Device Sequence Number: 15291074
• 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): 06/26/2024

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: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0032820769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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: 63 YR
• Patient Sex: Male