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); Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure to remove device occurred.A sentinel cerebral protection system (cps) was used during a procedure.A non-boston scientific radial introducer sheath was used.At the end of the procedure during withdrawal, the sentinel cps tip got stuck inside the non-bsc radial introducer sheath and could not be removed.The sentinel cps was cut and the entire non-bsc radial introducer sheath was removed.No adverse events occured.
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, part # cms15-10c-us, batch # 0038087753.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 was returned for device analysis.It was observed that both articulating distal sheath and distal filter were cut by the customer in order to remove the non-boston scientific (bsc) sheath and the proximal sheath was kinked.Investigation conclusion bsc has assigned an investigation conclusion code of adverse event related to procedure.Device analysis confirmed the reported failure to remove as the device was returned with the articulating distal sheath and distal filter cut in order to remove the non-bsc sheath.This type of event can occur due to interactions between devices as well as handling/technique during manipulation of the device.The proximal sheath was also noted to be kinked, which was not reported.This type of event can occur due to excessive forced as well as handling/technique during manipulation of the device.
Event or Problem Description
It was reported that failure to remove device occurred.A sentinel cerebral protection system (cps) was used during a procedure.A non-boston scientific radial introducer sheath was used.At the end of the procedure during withdrawal, the sentinel cps tip got stuck inside the non-bsc radial introducer sheath and could not be removed.The sentinel cps was cut and the entire non-bsc radial introducer sheath was removed.No adverse events occured.

• 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: 24561523
• Report Number: 2124215-2026-13223
• Device Sequence Number: 18515372
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: (01)00863229000004(17)271202(10)38087753
• 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): 04/15/2026

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: 0038087753
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown