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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2020
Event Type  malfunction  
Event Description
It was reported that the distal filter failed to capture.A sentinel embolic protection device was placed.At the end of the case, resistance felt when retrieving the distal filter.The distal filter slider (#3) on the handle broke.The distal filter was pulled partially back into the sheath but was unable to be fully recaptured prior to removal of the patient.No patient consequences were reported.
 
Manufacturer Narrative
H3: device eval by manufacturer?: analysis of the returned device was conducted by a bsc quality engineer.The analysis found the inner member condition was not clear due to blood in the system.The distal filter slider (#3) was detached from the device (slider was not bent and had no visible fragments of the inner member).Both filters were returned un-sheathed, and the articulating distal sheath (ads) was not deflected.Testing showed flushing could not be performed through either the distal filter slider (#3) or the rear handle flush port.A test guidewire was fully advanced into the system; the proximal filter sheathed and un-sheathed using the proximal filter slider (#1), and ads articulation was achieved by turning the articulating knob (#2).However, the distal filter could not be sheathed/un-sheathed due to device condition.The reported complaints of handle break and distal filter failure to capture/retrieve were confirmed.Additional testing was performed in order to look further into the issue.The distal filter was able to be sheathed/ and un-sheathed by manually pulling the inner member (supported by a guidewire), and microscopic inspection found the filler tube appeared slightly wavy/buckled on top of the inner member, as well as damaged; no distal filter damage was found.Distal filter slider (#3) was submitted for x-ray inspection and no traces of inner member remains were found inside.Additionally, a.032 inches pin gage was inserted into the detached distal filter slider (#3).
 
Event Description
It was reported that the distal filter failed to capture.A sentinel embolic protection device was placed.At the end of the case, resistance felt when retrieving the distal filter.The distal filter slider (#3) on the handle broke.The distal filter was pulled partially back into the sheath but was unable to be fully recaptured prior to removal of the patient.No patient consequences were reported.
 
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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 Key10093104
MDR Text Key192254109
Report Number2134265-2020-07010
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 07/23/2020
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 Date03/17/2022
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0025364005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2020
Initial Date Manufacturer Received 05/08/2020
Initial Date FDA Received05/27/2020
Supplement Dates Manufacturer Received07/01/2020
Supplement Dates FDA Received07/23/2020
Patient Sequence Number1
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