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

Model Number	CMS15-10C-US
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via poster presentation that difficulty/failure to place device and stroke occurred.This presentation discussed evaluation of cases with difficulty deploying the sentinel during transfemoral transcatheter aortic valve implant procedures.A total of 102 cases in which the sentinel was used between (b)(6) 2025 and (b)(6) 2026 were analyzed to examine the anatomical characteristics and other factors in cases where placement was difficult.There were 12 cases of placement difficulty; in 5 of these, the entire device had to be removed due to the difficulty, while in 7 cases, only the proximal filter was partially placed because the distal filter could not be placed.Analysis of preoperative ct scans revealed that cases with placement difficulty involved tortuosity or calcification of the brachiocephalic artery.Cerebral infarction was observed in 2 cases within 30 days postoperatively; however, no other complications (such as vascular complications or major bleeding) were observed.
Event or Problem Description
It was reported via poster presentation that difficulty/failure to place device and stroke occurred.This presentation discussed evaluation of cases with difficulty deploying the sentinel during transfemoral transcatheter aortic valve implant procedures.A total of 102 cases in which the sentinel was used between february 2025 and march 2026 were analyzed to examine the anatomical characteristics and other factors in cases where placement was difficult.There were 12 cases of placement difficulty; in 5 of these, the entire device had to be removed due to the difficulty, while in 7 cases, only the proximal filter was partially placed because the distal filter could not be placed.Analysis of preoperative ct scans revealed that cases with placement difficulty involved tortuosity or calcification of the brachiocephalic artery.Cerebral infarction was observed in 2 cases within 30 days postoperatively; however, no other complications (such as vascular complications or major bleeding) were observed.
Additional Manufacturer Narrative
B3: bsc aware date used as event date is unknown.Jtvt2026 poster presentation information: presentation number: p11-5 title: cerebral embolic protection device use in tf-tavi at the facility: evaluation of cases with difficult device deployment.With all the available information, boston scientific (bsc) concludes: device history record review the batch number for the sentinel cerebral protection system (csp) was not provided.A ship history was performed to identify the three most recently shipped batches to the customer.A review was completed of the device history records (dhr) for the sentinel cps batch # 39316726, 39526574, 39545253.All devices from these batches were processed through all normal operation conditions and passed all acceptance activities.The dhr reviews did not identify any deviations or non-conformances that could contribute to the event.Device technical analysis the sentinel cps was not returned therefore analysis could not be completed.Investigation conclusion bsc has assigned an investigation conclusion code of adverse event related to procedure.
Additional Manufacturer Narrative
B3: bsc aware date used as event date is unknown.Jtvt2026 poster presentation information: presentation number: p11-5.Title: cerebral embolic protection device use in tf-tavi at the facility: evaluation of cases with difficult device deployment.

• 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: 50333752
• Report Number: 2124215-2026-44725
• Device Sequence Number: 17549004
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: (01)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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown