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 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2019.Event date was estimated to be (b)(6) 2019 based on when the event was reported.

Event Description

It was reported that the distal filter could not be recaptured.Procedure summary: a patient presented for a transcatheter aortic valve replacement (tavr) procedure.A sentinel device was used during the procedure.The sentinel device was passed over a choice pt wire and both proximal and distal filter were deployed successfully.Event summary: upon retrieval of the sentinel, the distal filter appeared not to be retracted into the distal sheath as the distal filter was being pulled back from the handle even though the hypotube was exposed and retracted and maximum length.As the physician manipulated hypotube, it broke free.The physician then attempted to open the rear handle by cracking it open with an edwards crimper to isolate the filament in order to pull the distal filter back into the sheath.The physician was unsuccessful in doing so.Ultimately, the sentinel was retrieved with the distal filter deployed.The distal filter was successfully removed and no harm to the patient occurred.

Event Description

It was reported that the distal filter could not be recaptured.Procedure summary: a patient presented for a transcatheter aortic valve replacement (tavr) procedure.A sentinel device was used during the procedure.The sentinel device was passed over a choice pt wire and both proximal and distal filter were deployed successfully.Event summary: upon retrieval of the sentinel, the distal filter appeared not to be retracted into the distal sheath as the distal filter was being pulled back from the handle even though the hypotube was exposed and retracted and maximum length.As the physician manipulated hypotube, it broke free.The physician then attempted to open the rear handle by cracking it open with an edwards crimper to isolate the filament in order to pull the distal filter back into the sheath.The physician was unsuccessful in doing so.Ultimately, the sentinel was retrieved with the distal filter deployed.The distal filter was successfully removed and no harm to the patient occurred.

Manufacturer Narrative

B3 - date of event: event date was estimated to be (b)(6) 2019 based on when the event was reported.H - device eval by manufacturer: visual inspection revealed marks on the rear handle shells indicating manipulation with another device/tool.The distal filter slider (#3) was returned detached.The inner member was exposed.A guidewire was still inside the device when returned.There was a kink found in the proximal sheath.Functional testing revealed the articulation sheath could flex and relax properly.Resistance was met when attempting to pull out the guide wire.The distal filter capture/retrieval could not be tested due to device condition.X-ray analysis was performed.No inner member remains were found inside the detached distal filter slider (#3).Due to the nature of the failure, the most probable cause of this complaint is manufacturing deficiency.Further investigation is being conducted.

• 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
• MDR Report Key: 9161735
• MDR Text Key: 166565541
• Report Number: 2134265-2019-11584
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

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 Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 19G31H27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR