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

Model Number CMS15-10C-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: the event date was not reported.The first day of the month of the aware date was used as an estimate.Device evaluated by manufacturer: the unit was returned with the distal filter slider fully detached.The distal filter was un-sheathed, inverted and the strut tube was broken.The proximal filter was un-sheathed and the articulating distal sheath (ads) was relaxed.The rear handle shells and distal filter coupler were unraveled and the tri-layer was detached.Testing of the device noted that flushing was achieved through front handle flush port, however, flushing was not achieved through the rear handle flush port.Fluid went backwards due to the detached component.Flushing could not be performed through distal filter slider.A test guidewire was fully inserted and the ads responded as expected when turning the articulating knob.The proximal filter sheathed and un-sheathed using the proximal filter slider.The distal filter could not be sheathed or un-sheathed due to the distal filter slider detachment.Apparent adhesive residues were visible in the distal filter coupler and manual sheathing of the distal filter was attempted with guidewire support, but could not be achieved.

Event Description

Reportable based on analysis completed on 13-aug-2020.The sentinel cerebral protection system was returned for analysis without any previously reported incidents.Analysis revealed that the device appeared to have been used and the distal filter strut tube was broken.

• 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: 10525251
• MDR Text Key: 209803524
• Report Number: 2134265-2020-12517
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0025474436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1