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

Model Number	M001508140
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient in interventional radiology for ir carotid arteriogram: wire broke off prior to being inserted into the body.No patient harms.Patient presented to emergency in re cerebrovascular accident due to occlusion of right middle cerebral artery resulting in acute left-sided weakness.Angiography head/neck indicated.Interventional neurology suite for clot retrieval, patient ended up getting tnkase and taken to interventional suite for attempted thrombectomy.Patient had significant extracranial right carotid stenosis requiring angioplasty after which patient had adequate right mca flow.No thrombectomy was performed.Patient extubated and brought to icu.

• Brand Name: FATHOM -14
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 20236107
• Report Number: 20236107
• Device Sequence Number: 8667433
• Product Code: DQX
• UDI-Device Identifier: 08714729801047
• UDI-Public: (01)08714729801047(17)25012(10)30336899
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/28/2024
• Report Date (Section F): 05/29/2024

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
• Device Model Number: M001508140
• Device Catalogue Number: M001508140
• Device Lot Number: 30336899
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Date Report Sent to FDA: 05/29/2024