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); Material Integrity Problem (2978); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that partial filter detachment occurred.A procedure was being performed with use of a sentinel cerebral protection system (cps).During the procedure, there was difficulty deploying the proximal filter and difficulty operating the proximal filter slider #1.The proximal filter was recaptured and repositioned.It was noted that the proximal filter was partially detached from the filter hoop.The physician noted that the difficulty deploying the device may have been related to the catheter being moved together with the device after deployment of the proximal filter.A new sentinel was utilized to complete the procedure.No patient complications 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 # 0038610362.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 discarded, therefore returned device analysis could not be completed.Investigation conclusion: bsc has assigned an investigation conclusion code of adverse event related to procedure.It is likely that the event could be related to excessive force applied to the device and/or operational factors such as handling/manipulation during the procedure.

• 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: 25222680
• Report Number: 2124215-2026-27005
• Device Sequence Number: 9778581
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: (01)00863229000004(17)280216(10)38610362
• 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): 05/19/2026

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: 0038610362
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 02/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown