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

Model Number	81725
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that guidewire fracture occurred, requiring snare for removal.A 200 cm x 10 cm fathom -14 guidewire was selected for use in the treatment of vascular stenosis in the subclavian artery.However, the guidewire was fractured upon withdrawal and snaring was performed to remove the device.No patient complications were reported, and the patient status stable.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the fathom - 14 guidewire was returned for analysis.It was observed that the device was bent, stretched detached at distal tip.The reported event of guidewire fracture was confirmed.
Event or Problem Description
It was reported that guidewire fracture occurred, requiring snare for removal.A 200 cm x 10 cm fathom -14 guidewire was selected for use in the treatment of vascular stenosis in the subclavian artery.However, the guidewire was fractured upon withdrawal and snaring was performed to remove the device.No patient complications were reported, and the patient status 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: 20326477
• Report Number: 2124215-2024-60669
• Device Sequence Number: 7782218
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: 08714729801023
• 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): 11/26/2024

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: 0033603528
• 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: 09/14/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male