MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM? -16; WIRE, GUIDE, CATHETER

Model Number	M001509210
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to (b)(6) 2025 as the exact event date was not reported.Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that tip detachment occurred.The stenosed target lesion was located in the moderately tortuous vessel.A fathom -16 guidewire was selected for use in a visceral angiogram.During the procedure, it was noted that the tip of the wire inadvertently sheared off into the branch of superior mesenteric artery.The tip of the wire was completely removed with a gooseneck snare.A repeat angiogram was performed and confirmed the resolution of hemorrhage.Patient was stable and scheduled for a colonoscopy.
Event or Problem Description
It was reported that tip detachment occurred via attached voluntary medwatch report # (b)(4).The stenosed target lesion was located in the moderately tortuous vessel.A fathom -16 guidewire was selected for use in a visceral angiogram.During the procedure, it was noted that the tip of the wire inadvertently sheared off into the branch of superior mesenteric artery.The tip of the wire was completely removed with a gooseneck snare.A repeat angiogram was performed and confirmed the resolution of hemorrhage.Patient was stable and scheduled for a colonoscopy.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 03/01/2025 as the exact event date was not reported.Device evaluation by manufacturer: the device was returned for analysis and inspected according to procedure.The guidewire was returned, and during visual inspection it was observed that the distal tip was detached.Microscopic inspection confirmed that the guidewire was detached.Product analysis confirmed the reported tip detachment.

• Brand Name: FATHOM? -16
• 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: 21954315
• Report Number: 2124215-2025-26696
• Device Sequence Number: 8547633
• Product Code: DQX
• UDI-Device Identifier: 08714729961123
• UDI-Public: (01)08714729961123
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K170636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: M001509210
• Device Catalogue Number: M001509210
• Device Lot Number: 0035141563
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White