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

Model Number	M001508100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device separation occurred and it was removed with a snare.A 200 cm x 10 cm fathom-14 was selected for use to perform a pre-y90 mapping.During the procedure, the fathom wire broke off and remained in the patient's body.The broken part of the wire was completely removed from the patient's body with a snare and the procedure was completed.No further complications were reported and the patient is stable after the procedure.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.
Event or Problem Description
It was reported that a device separation occurred and it was removed with a snare.A 200 cm x 10 cm fathom-14 was selected for use to perform a pre-y90 mapping.During the procedure, the fathom wire broke off and remained in the patient's body.The broken part of the wire was completely removed from the patient with a snare and the procedure was completed.No further complications were reported and the patient is stable after the procedure.

• 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: 18156273
• Report Number: 2124215-2023-63129
• Device Sequence Number: 15453605
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: (01)08714729801023(17)260627(10)31918631
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 07/03/2024

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 Expiration Date: 06/27/2026
• Device Model Number: M001508100
• Device Catalogue Number: 81725
• Device Lot Number: 0031918631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2023
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown