MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE

Model Number CMS15-10C-US

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Event Description

It was reported that inability to resheath the distal filter occurred.A patient with mild stenosis, mild tortuosity and moderate calcification was selected for a transcatheter aortic valve replacement(tavr) procedure.A sentinel cerebral protection system was used during the procedure.After insertion, the sentinel cerebral protection system (lot:0025786901) would not articulate.The sentinel cerebral protection system was removed from the patient and exchanged for a new sentinel cerebral protection system(unknown lot).The new sentinel cerebral protection system(unknown lot) was prepped and inserted without incident.After the tavr procedure, while attempting to resheath the distal filter, the distal filter slider hypotube broke.The distal filter was unable to be resheathed.The sentinel cerebral protection system was removed from the patient with the distal filter in an open state.No patient complications occurred.The patient is fine.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill parkway; santa rosa CA 95403
• 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: 10781905
• MDR Text Key: 214525571
• Report Number: 2134265-2020-15058
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN160043
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• 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: 10/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 94