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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 08/04/2020
Event Type  malfunction  
Event Description
It was reported that the distal filter could not be fully resheathed for removal.A sentinel cerebral protection system was used during a transcatheter aortic valve replacement (tavr) procedure.At the end of the procedure, the distal filter was unable to be resheathed and the handle broke.There were no patient complications reported.
 
Event Description
It was reported that the distal filter could not be fully resheathed for removal.A sentinel cerebral protection system was used during a transcatheter aortic valve replacement (tavr) procedure.At the end of the procedure, the distal filter was unable to be resheathed and the handle broke.There were no patient complications reported.
 
Manufacturer Narrative
H3 - device evaluated by manufacturer: the unit was returned with a unknow guidewire inserted within the device and a unknown introducer sheath with the distal end of the device introduced in it.The inner member was protruding approximately 10cm from the proximal end of the device.Distal filter slider (#3) was detached with the unknown guidewire still inserted in it.The portion of the inner member under the rear handle shells was without visible damage.The proximal and distal filters were returned sheathed.The articulating distal sheath (ads) was relaxed with a kink.Flushing was unable to be performed through the distal filter slider (#3) due to detachment.Flushing was achieved as expected through the front and rear handle flush ports.Microscopic inspection confirmed detachment of the inner member from the hypotube.Functional testing was conducted.The unknown introducer sheath was able to be removed.The proximal filter sheathed/un-sheathed using the proximal filter slider (#1).The ads responded as expected when turning the articulating knob (#2).The distal filter could not be sheathed/un-sheathed due to distal filter slider (#3) detachment.Manual un-sheathing of the distal filter was able to be performed with support from the returned unknown guidewire.
 
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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 Key10407963
MDR Text Key202949676
Report Number2134265-2020-10845
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 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/24/2022
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0025638539
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2020
Date Manufacturer Received09/22/2020
Patient Sequence Number1
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