MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL; EMBOLIC PROTECTION DEVICE

Model Number	CMS15-10C-US
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device detachment occurred.A transcatheter aortic valve replacement procedure was being performed, and a sentinel cerebral protection system (cps) was utilized for embolic protection.The sentinel cps was kinked and could not be delivered to the position due to the tortuous anatomy.Difficulty was encountered during removal of the device from the patient anatomy.After removal, the sentinel cps was exchanged for another to successfully complete the procedure.No patient complications were reported.The first sentinel cps was returned to boston scientific for analysis.Upon analysis, the proximal filter, distal filter, articulating distal sheath (ads) and a portion of the inner member were detached and not returned for analysis.It was reported that the detachment was attributable to the tortuous anatomy.Further information on the cause of the detachment and if it occurred during the procedure or after removed from the anatomy remains unknown.
Additional Manufacturer Narrative
A1: patient identifier added.
Event or Problem Description
It was reported that device detachment occurred.A transcatheter aortic valve replacement procedure was being performed, and a sentinel cerebral protection system (cps) was utilized for embolic protection.The sentinel cps was kinked and could not be delivered to the position due to the tortuous anatomy.Difficulty was encountered during removal of the device from the patient anatomy.After removal, the sentinel cps was exchanged for another to successfully complete the procedure.No patient complications were reported.The first sentinel cps was returned to boston scientific for analysis.Upon analysis, the proximal filter, distal filter, articulating distal sheath (ads) and a portion of the inner member were detached and not returned for analysis.It was reported that the detachment was attributable to the tortuous anatomy.Further information on the cause of the detachment and if it occurred during the procedure or after removed from the anatomy remains unknown.

• Brand Name: SENTINEL
• Common Device Name: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22955057
• Report Number: 2124215-2025-61596
• Device Sequence Number: 15862224
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: (01)00863229000004(17)260430(10)33934293
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192460
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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 Expiration Date: 04/30/2026
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0033934293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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
• Patient Sex: Male
• Patient Weight: 65 KG