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

Model Number CMS15-10C-US

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Device eval by manufacturer: the sentinel was returned to boston scientific and was analyzed by a bsc quality engineer.The sentinel was returned with a unknown introducer sheath.During the visual inspection, the distal filter slider (#3) was found kinked.The outer shaft was also noted to be buckled at the distal end.The proximal filter was partially un-sheathed and the distal filter was returned sheathed.The articulating distal sheath(ads) was noted to be pinched.X-ray inspection revealed the ads inner wire was broken, next to the distal filter.Functional testing revealed that flushing was able to be achieved in all flush ports.The test guidewire could not be fully inserted from the distal end due to the pinched damage in the ads.The proximal filter was fully un-sheathed using the proximal filter slider, however, when the proximal filter was fully out, the pull wire of the proximal filter was found detached from its joint and the proximal filter was found torn.The ads responded as expected when turning the articulating knob (#2) even with the damages found.The distal filter could not be un-sheathed using the distal filter slider (#3) due to the kink.The distal filter was able to be sheathed and un-sheathed properly when the kink of the distal filter slider (#3) was removed.

Event Description

Reportable based on returned device analysis completed in 11-sep-2020.It was reported that the choice pt guidewire was stuck inside the sentinel cerebral protection system.A sentinel cerebral protection system was selected for a transcatheter aortic valve replacement(tavr) procedure.The proximal filter was successfully deployed, but the distal filter was unable to be deployed as the 0.014 choice pt guidewire was unable to be retracted through the sentinel device.The sentinel could not be removed from the radial sheath separately, so the physician removed the sentinel and the sheath together.Upon removal, the proximal end of the choice pt guidewire was noted to be bent.A new right radial sheath was placed over a new choice pt guidewire and a second sentinel cerebral protection system was deployed without difficulty.However, the returned device analysis revealed that the proximal filter on the sentinel cerebral protection system was torn.

• 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: 10583138
• MDR Text Key: 208515440
• Report Number: 2134265-2020-13253
• 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: 09/24/2020

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 Expiration Date: 06/17/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0025610807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1