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

Model Number CMS15-10C

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2019

Event Type  malfunction  

Event Description

It was reported that the sentinel embolic protection device moved out of its deployed position in the patient.The patient presented for a transcatheter aortic valve replacement (tavr) and watchman combined procedure.The patient was under general anesthetic for the procedure.The sentinel embolic protection device was positioned according to directions for use (dfu).The patients arm was placed away, and the tavr procedure was initiated.After the valve was deployed, the patient started waking up.Their arm moved and it fell from the table.This caused the sentinel embolic protection device to move; the distal filter disengaged from the left common carotid (lcc).The sentinel embolic protection device was then removed with the distal filter fully re-sheathed.Because the physician had not fully turned the articulation knob to straighten the distal end of the device there was a slight curve that made it difficult to withdraw through the introducer sheath.It was decided to fully remove the introducer sheath together with the sentinel device.The physician then did a brachial approach to complete with a new sentinel device to complete the watchman procedure.The procedure was completed without any further issue.The patient was reported to be recovering from the tavr and watchman procedure per standard of care.Of note, the patients arm was tucked in during the procedure, but not as securely as it should have been.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill parkway; suite 1; santa rosa CA 95403
• Manufacturer (Section G): CLARET MEDICAL, INC.; 1745 copperhill parkway; suite 1; santa rosa CA 95403
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9200232
• MDR Text Key: 164327741
• Report Number: 2134265-2019-12391
• 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: 10/16/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 19D23H25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• 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