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

Model Number CMS15-10C

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

It was reported that an inability to resheath the distal filter occurred.A sentinel embolic protection device was placed for use during a transcatheter aortic valve implant (tavi) procedure.The proximal and distal filters were successfully deployed.After the tavi procedure, the physician was attempting to resheath the distal filter when the distal filter slider broke off the handle of the sentinel embolic protection system.The physician was unable to resheath the distal filter.The physician was able to resheath the proximal filter without any issue.The sentinel embolic protection device was removed from the patient over the guide wire with the distal filter unsheathed.No patient complications were reported.The patient has fully recovered.

Event Description

It was reported that an inability to resheath the distal filter occurred.A sentinel embolic protection device was placed for use during a transcatheter aortic valve implant (tavi) procedure.The proximal and distal filters were successfully deployed.After the tavi procedure, the physician was attempting to resheath the distal filter when the distal filter slider broke off the handle of the sentinel embolic protection system.The physician was unable to resheath the distal filter.The physician was able to resheath the proximal filter without any issue.The sentinel embolic protection device was removed from the patient over the guide wire with the distal filter unsheathed.No patient complications were reported.The patient has fully recovered.

Manufacturer Narrative

H3 device evaluated by mfr: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Visual inspection of the returned device revealed the unit was returned with the following conditions: the distal filter slider (#3) kinked, the proximal filter sheathed and the distal filter un-sheathed.Xray inspection revealed clean detachment of the inner member from the hypotube.Flushing was achieved as expected through distal filter slider (#3).The distal filter could not be sheathed/un-sheathed due to clean detachment of the inner member from the hypotube in distal filter slider (#3).

• 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
• MDR Report Key: 10534714
• MDR Text Key: 206952367
• Report Number: 2134265-2020-12453
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• PMA/PMN Number: DEN160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2022
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0025786902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Date Manufacturer Received: 10/23/2020
• Patient Sequence Number: 1
• Patient Age: 75 YR