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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE
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CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE Back to Search Results
Model Number CMS15-10C-US
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/14/2020
Event Type  malfunction  
Event Description
It was reported that the distal filter was unable to be fully resheathed.A sentinel embolic protection system was placed.During the retrieval of the distal filter, the distal filter slider on the handle separated.The distal filter was unable to be fully resheathed and was removed from the patient in a partially sheathed state.No patient complications were reported.The patient is stable.
 
Event Description
It was reported that the distal filter was unable to be fully resheathed.A sentinel embolic protection system was placed.During the retrieval of the distal filter, the distal filter slider on the handle separated.The distal filter was unable to be fully resheathed and was removed from the patient in a partially sheathed state.No patient complications were reported.The patient is stable.It was further reported that there was resistance while attempting to re-sheath the distal slider.The device appeared to be completely separated from the wire and bent upon examining after removal.
 
Manufacturer Narrative
New information: b5: describe event or problem h3: device eval by manufacturer? analysis of the returned device was completed by a bsc quality engineer.It was noted the distal filter slider (#3) was detached and slightly bent, the proximal filter was un-sheathed (with blood traces and torn) and the outer sheath kinked.The articulating distal sheath(ads) was pinched and the distal filter was sheathed and although there were no inner member damages visible under the rear handle shells, both the inner member and the filler tuber were found exposed and kinked/damaged.Flushing was achieved through rear handle and front handle flush port, but not through the distal filter slider (#3).During testing, the proximal filter was sheathed/un-sheathed using proximal filter slider (#1), however the test guidewire could not be inserted and distal filter sheathing/un-sheathing could not be tested due to missing slider.The reported allegations of handle break and distal filter failure to capture/retrieve were confirmed due to device condition.Additional testing was performed in order to look further into the issue.The device was submitted for x-ray inspection and it was confirmed that there were no inner member pieces inside the detached distal filter slider (#3), and the distal filter coupler was unraveled.The ads responded as expected when turning articulating knob (#2), and the distal filter was un-sheathed by manually pushing the inner member using a guidewire as support (during the process, the filler tube buckled).During a second x-ray inspection, after un-sheathing the distal filter, no irregularities were found in the ads.
 
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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 Key10123686
MDR Text Key194161147
Report Number2134265-2020-07396
Device Sequence Number1
Product Code PUM
UDI-Device Identifier00863229000004
UDI-Public00863229000004
Combination Product (y/n)N
PMA/PMN Number
DEN160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/11/2022
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0025207013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2020
Date Manufacturer Received07/09/2020
Patient Sequence Number1
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