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

Model Number	CMS15-10C-US
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that filter failed to recapture.A transcatheter aortic valve replacement (tavr) procedure was being performed, and a sentinel cerebral embolic protection (cep) device was selected for use.The sentinel cep was inserted, and the distal filter was deployed, however the distal filter could not be retracted, and the filter hoop could not be retracted into the sheath, so it was removed along with the sheath.

• 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: 24039190
• Report Number: 2124215-2026-01845
• Device Sequence Number: 16076897
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 09/13/2026
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0034845271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 09/13/2024
• 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 Age: 84 YR
• Patient Sex: Male