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	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure to recapture filter occurred.A transcatheter aortic valve replacement (tavr) procedure was being performed.A sentinel cerebral protection system (cps) was selected for embolic protection.The sentinel cps was advanced to the intended location.The distal filter was deployed, however upon attempt to re-sheath and re-position, the distal filter failed to re-sheath despite attempts to advance and retract the distal filter slider #3.The device was removed safely with the distal filter in an open state.No additional intervention was required for removal and no patient complication occurred.The tavr procedure was completed without cerebral embolic protection.

• 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: 25037030
• Report Number: 2124215-2026-23299
• Device Sequence Number: 10411484
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: (01)00863229000004(17)280330(10)38972881
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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 Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0038972881
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 03/31/2026
• 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: Unknown