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 04/01/2020

Event Type  malfunction  

Event Description

It was reported that the distal filter failed to retrieve.A sentinel cerebral protection system was used during a procedure.The mandrel broke when trying to retrieve the distal filter.The proximal filter was retrieved but they could not retrieve the distal filter.Maneuvers were tried, however, were unsuccessful.The distal filter was pulled through the radial sheath open without resistance.No patient complications were reported.

Manufacturer Narrative

H3: device eval by manufacturer: the device was returned to bsc and reviewed by a bsc quality engineer.Analysis of the returned device found the proximal filter fully sheathed and distal filter fully un-sheathed, distal filter slider (#3) hypotube was detached (not returned with the device) and the rear handle lock in a guidewire; inner member condition under rear handle shells was not visible due to high amount of blood residue present.Testing showed flushing was able to be performed through the front handle flush port but not through the distal filter slider (#3) or rear handle flush port.A test guidewire was able to fully cross, proximal filter un-sheathes/sheathes using the proximal filter slider (#1), and the articulating distal sheath (ads) responded as expected when turning articulating knob (#2).However, distal filter sheathing/un-sheathing could not be tested due to missing distal filter slider (#3).Additional analysis showed the distal filter was able to be fully sheathed by manually pulling the inner member (supported by a guidewire).It was also visible that the distal filter had no damages, but the filler tube was buckled and damaged.No abnormalities were found during x-ray analysis.

Event Description

It was reported that the distal filter failed to retrieve.A sentinel cerebral protection system was used during a procedure.The mandrel broke when trying to retrieve the distal filter.The proximal filter was retrieved but they could not retrieve the distal filter.Maneuvers were tried, however, were unsuccessful.The distal filter was pulled through the radial sheath open without resistance.No patient complications were reported.

• 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: 10048086
• MDR Text Key: 191010506
• Report Number: 2134265-2020-06281
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0025119281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Date Manufacturer Received: 06/08/2020
• Patient Sequence Number: 1