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

Model Number CMS15-10C

Device Problems Device-Device Incompatibility (2919); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Event Description

Protected tavr study.It was reported that loss of position occurred.Prior to the index procedure, heparin or other anticoagulant was given.The subject was not on a prior regimen of aspirin and antiplatelet other than aspirin at the time of index procedure.The subject received loading dose of aspirin and clopidogrel.After heparin had been given, the activated clotting time (act) was 153 sec.An introducer was placed into right radial artery and a sentinel cerebral protection system was inserted with the proximal filter into brachiocephalic artery, and the distal filter into left common carotid artery.There was mild tortuosity and mild calcification at the ostium of the great vessels, with minimal stenosis.A non boston scientific valve was advanced through the aortic arch, it interreacted with the sentinel cerebral protection system, resulting in dislodgement of the distal filter from left common carotid artery.The filter in right common carotid artery remained in place.Attempts were made to reposition the sentinel cerebral protection system, however, unsuccessful.The non boston scientific valve was implanted and the sentinel cerebral protection system was successfully retrieved without any complications.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• 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: 10623316
• MDR Text Key: 209792323
• Report Number: 2134265-2020-13423
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: DEN160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2021
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0024902664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR