MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE

Model Number CMS15-10C

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the sentinel cps was returned and analyzed by a bsc quality technician.Visual analysis revealed a sheathed proximal filter, relaxed articulating distal sheath (ads), sheathed distal filter, kinked distal filter slider (#3), and torn proximal filter.A functional test was performed and found that the distal filter could not be unsheathed using the distal filter slider (#3) due to the kink.The proximal filter was able to be successfully unsheathed using the proximal filter slider (#1).A flow test was performed successfully on the front handle flush port and rear handle flush port without issue.A flow test could not be performed on the distal filter slider (#3) due to the kink.

Event Description

Reportable based on returned device analysis completed 28 february 2024.It was reported that a failure to articulate the device occurred.A sentinel cerebral protection system (cps) was selected for a transcatheter aortic valve implantation (tavi) procedure.The sentinel cps was advanced and positioned with the proximal filter into the brachiocephalic artery.The proximal filter was successfully deployed into the brachiocephalic artery.Upon cannulating to the left common carotid artery with the articulating distal sheath, torque was not delivered to the angulation sheath, thus, the articulating sheath section of the sentinel cps did not effectively articulate into the left common carotid for subsequent distal filter deployment.The proximal filter was recaptured, and the sentinel cps was removed from the patient.The procedure was completed with no sentinel cps in place.No patient complications were reported.However, returned device analysis found the proximal filter was torn.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION DEVICE
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18832556
• MDR Text Key: 336986925
• Report Number: 2124215-2024-12649
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0031607022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Date Device Manufactured: 05/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1