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

Model Number	CMS15-10C-US
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528); Material Integrity Problem (2978); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure to recapture filters occurred.A sentinel cerebral protection system (cps) was selected for embolic protection during a transcatheter aortic valve replacement (tavr) procedure.The sentinel cps was advanced into the anatomy.The proximal and distal filters were deployed but moved out of position during deployment.Both filters were recaptured two times and during the third attempt, the physician was unable to fully recapture the proximal and distal filters and unable to pull the front and rear handles together.After removing the sentinel cps from the anatomy, the physician was unable to deploy the filters easily.The tavr procedure was completed using an alternate cps.No patient complications occurred.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned sentinel was received for analysis.The sentinel was returned with the proximal filter sheathed, the articulating distal sheath relaxed, and the distal filter unsheathed.Functional testing was performed.The distal filter could be recaptured and re-deployed using the distal filter slider #3 without any issues.The proximal filter could be deployed and recaptured using the proximal filter slider #1 without any issues.The reported events of proximal and distal filters difficult to maintain position/reposition could not confirmed as clinical conditions could not be replicated.The reported events of handle damaged/defective, proximal filter failure to capture/retrieve, proximal filter failure to deploy, distal filter failure to deploy, and distal filter failure to capture/retrieve could not be confirmed through device analysis as the proximal and distal filters were both able to be deployed and recaptured without issue using the sliders on the handle.Photo included from the field was reviewed by a bsc technician.The photo showed the proximal filter completely deployed.
Event or Problem Description
It was reported that failure to recapture filters occurred.A sentinel cerebral protection system (cps) was selected for embolic protection during a transcatheter aortic valve replacement (tavr) procedure.The sentinel cps was advanced into the anatomy.The proximal and distal filters were deployed but moved out of position during deployment.Both filters were recaptured two times and during the third attempt, the physician was unable to fully recapture the proximal and distal filters and unable to pull the front and rear handles together.After removing the sentinel cps from the anatomy, the physician was unable to deploy the filters easily.The tavr procedure was completed using an alternate cps.No patient complications 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: 22686345
• Report Number: 2124215-2025-50788
• Device Sequence Number: 9000333
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: (01)00863229000004(17)270109(10)35593303
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/08/2025

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: 0035593303
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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