MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL; TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES

Model Number	CMS15-10C-US
Medical Device Problem Codes	Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the sentinel was received for analysis.Visual inspection identified the unit returned with the proximal filter unsheathed, the articulating distal sheath relaxed, the distal filter partially unsheathed, and no kinks or bends on the proximal sheath.Microscopic inspection identified the proximal filter to be partially detached from the looping forming.The partial detachment of the proximal filter can be attributed to excessive force applied to the device during attempted insertion, as well as operational factors such as handling/technique while manipulating the device.
Event or Problem Description
Reportable upon analysis 11 nov 2025.It was reported that difficulty inserting device occurred.A sentinel cerebral protection system (cps) was selected for embolic protection during a transcatheter aortic valve implant (tavi) procedure.While attempting to insert the device into the severely tortuous anatomy, difficulty was encountered.The sentinel cps was removed without issue and a new sentinel cps was utilized to complete the procedure.There were no patient complications.The device was received back for analysis with the proximal filter was partially detached from the looping forming.

• 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 ; 7634941632
• MDR Report Key: 23585493
• Report Number: 2124215-2025-82221
• Device Sequence Number: 9398357
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: (01)00863229000004(17)270409(10)36263025
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/18/2025

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 Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0036263025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown