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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); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
Event Type  malfunction  
Event Description
It was reported that failure to recapture the distal filter occurred.A sentinel cerebral protection system was used during a procedure.While attempting to re-sheath the distal filter for device removal, the #3 slider on the handle broke.The physician was able to use a clamp to grab part of the handle and retract the distal filter.Everything came back easily.The patient was in good condition post procedure and has been discharged with no signs of an adverse event.
 
Manufacturer Narrative
H3 - device evaluated by manufacturer: analysis of the returned unit evidenced the distal filter was mostly deployed (coupler slightly sheathed) and the articulating distal sheath (ads) was severely kinked and twisted, and had pinch marks in it.It was also noted that the introducer sheath came back with the sheath wrapped around proximal end of the ads, front rhv is slightly closed and handle shells were slightly separated.Rear rhv is separated from the device and the inner member was exposed from the rear handle and kinked.Rear handle hypotube was found broken and the inner member was completely detached from it.Functional testing of the device showed flushing was possible only through the rear and front handle flush ports, and the #2 knob still articulates the ads.A test guidewire was able to rout through the whole device successfully, severe protrusion from either the pullwire or the ribbon was noted in the pebax and the filet between coreshaft and skeleton fell off.The distal filter could not be sheathed due to damages found.Additional inspection was performed in order to look further into the issue.Inner member was removed from device and its filler tube bond is intact; filler tube to distal hypotube bond failed, which likely lead to the inner member breaking inside the hypotube.Distal filter looks as expected and can be sheathed and unsheathed using another undamaged ads.
 
Event Description
It was reported that failure to recapture the distal filter occurred.A sentinel cerebral protection system was used during a procedure.While attempting to re-sheath the distal filter for device removal, the #3 slider on the handle broke.The physician was able to use a clamp to grab part of the handle and retract the distal filter.Everything came back easily.The patient was in good condition post procedure and has been discharged with no signs of an adverse event.
 
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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 Key9232809
MDR Text Key167865068
Report Number2134265-2019-12249
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 01/08/2020
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 Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number19G31H27
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Initial Date Manufacturer Received 10/01/2019
Initial Date FDA Received10/24/2019
Supplement Dates Manufacturer Received12/19/2019
Supplement Dates FDA Received01/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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