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

Model Number	CMS15-10C-US
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device detachment and failure to recapture proximal filter occurred.A transcatheter aortic valve replacement (tavr) was being performed with a sentinel cerebral embolic protection (cps) for embolic protection.After the tavr procedure, during retrieval of the sentinel cps, the proximal filter encountered difficulty recapturing.It was noticed that the proximal sheath radiopaque marker had detached and became entangled with the proximal filter, preventing recapture of the proximal filter.No additional intervention was required, and the device was removed from the patient anatomy with the proximal filter in the open, entangled state.No patient adverse events occurred.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device history record review a review was completed of the device history records (dhr) for the sentinel cerebral protection system (cps), part # cms15-10c-us, batch # 0037049127.The device was processed through all normal operational conditions and passed all acceptance activities.The dhr review did not identify any deviations or non-conformances that could have contributed to the event.Device technical analysis the sentinel cps was returned for device analysis.The unit was returned with the proximal filter sheathed, the articulating distal sheath relaxed, the distal filter sheathed, and the proximal sheath accordioned.The sentinel was returned with the introducer sheath loaded and it could not be removed due to damage on the proximal sheath.Microscopic inspection identified the radiopaque marker to be detached and entangled with the proximal filter.The proximal filter was also partially detached from the hoop.The proximal filter was unable to be recaptured due to the detached/entangled radiopaque marker and damage to the proximal sheath.Media was provided for review.The media showed the radiopaque marker of the proximal filter detached and entangled with the proximal filter, consistent with what was reported and observed upon device analysis.Investigation conclusion bsc has assigned an investigation conclusion code of adverse event related to procedure.It was reported that the proximal filter encountered difficulty recapturing, the proximal sheath radiopaque marker was detached and entangled with the proximal filter.The device was returned, and analysis was consistent with the reported events.Device analysis also identified a partial detachment of the proximal filter from the hoop, and the proximal sheath to be accordioned.The reported and observed damaged is consistent with excessive force applied during the procedure as well as operational factors such as handling/technique.
Event or Problem Description
It was reported that device detachment and failure to recapture proximal filter occurred.A transcatheter aortic valve replacement (tavr) was being performed with a sentinel cerebral embolic protection (cps) for embolic protection.After the tavr procedure, during retrieval of the sentinel cps, the proximal filter encountered difficulty recapturing.It was noticed that the proximal sheath radiopaque marker had detached and became entangled with the proximal filter, preventing recapture of the proximal filter.No additional intervention was required, and the device was removed from the patient anatomy with the proximal filter in the open, entangled state.No patient adverse events occurred.

• 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: 24443886
• Report Number: 2124215-2026-10409
• Device Sequence Number: 10364108
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: (01)00863229000004(17)270724(10)37049127
• 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,Followup
• Report Date (Section B): 04/09/2026

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: 0037049127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 07/24/2025
• 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