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

Model Number CMS15-10C-US

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2021

Event Type  malfunction  

Event Description

It was reported that the distal filter of a sentinel cerebral protection system broke off in the carotid artery.A sentinel cerebral protection system was used during a transcatheter aortic valve replacement(tavr) procedure.During the procedure, the sentinel cerebral protection system distal filter broke off in the carotid artery.The physician recovered the distal filter.No patient complications were reported.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 160 knowles drive; los gatos CA 95032
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11225444
• MDR Text Key: 228634342
• Report Number: 2134265-2021-00707
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1