MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Sentinel; temporary catheter, embolic protection, transcatheter intracardiac procedures

Model Number	CMS15-10C-US
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a cerebral vascular accident.A sentinel cerebral protection system (cps) was utilized for embolic protection during a transcatheter aortic valve replacement (tavr) procedure.One day post-procedure, the patient experienced a cerebral vascular accident.The patient is hospitalized and receiving medication and other management.The patients symptoms are improving.The physician assessed the event as related to the sentinel cps procedure and the tavr procedure.

• Brand Name: Sentinel
• Common Device Name: temporary catheter, embolic protection, transcatheter intracardiac procedures
• 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 ; +1(612)875-7234
• MDR Report Key: 50736515
• Report Number: 2124215-2026-48756
• Device Sequence Number: 18801368
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/30/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female