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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); Failure to Advance (2524); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2019
Event Type  malfunction  
Event Description
It was reported that the distal filter was unable to be re-sheathed.Two sentinel cerebral protection system devices were attempted to be used during a procedure.The first sentinel cerebral protection system was not used as the guidewire could not be advanced.The second sentinel cerebral protection system was then prepped for use and inserted into the patient.While deploying the distal filter, it moved out of position from the left common carotid artery due to the patient's anatomy being tortuous.Attempts were made to re-sheath the filter for repositioning, and the handle broke.Re-sheathing was unsuccessful.The distal filter was not able to be recaptured.The entire device was retrieved without difficulties or injury to the patient.The procedure proceeded without use of a sentinel cerebral protection system.
 
Manufacturer Narrative
Analysis of the returned unit revealed the distal filter slider (#3) was detached, none of the filters were returned in a deployed condition, and part of the inner member was exposed through the rear handle.Functional tests were performed and articulating sheath was able to flex/relax properly, flushing could only be performed trough front handle flush port, and the proximal filter was able to be deployed and retracted using proximal filter slider (#1); however, distal filter tests could not be performed due to the condition of the returned device.Reported complaints of distal filter failure to capture/retrieve, and handle break were confirmed due to the condition of the returned device; however reported complaints of device failure to advance and distal filter failure to maintain position/reposition could not be confirmed as the procedural/anatomical conditions could not be replicated during testing.In order to look further into the issue, a test guidewire was inserted trough the exposed part of the innermember and, using it as support, the innermember was able to be move forward and backwards making distal filter deployment and retraction possible.Device was also sent for x-ray analysis and it was noted that there were no inner member pieces found inside the detached distal filter slider (#3).
 
Event Description
It was reported that the distal filter was unable to be re-sheathed.Two sentinel cerebral protection system devices were attempted to be used during a procedure.The first sentinel cerebral protection system was not used as the guidewire could not be advanced.The second sentinel cerebral protection system was then prepped for use and inserted into the patient.While deploying the distal filter, it moved out of position from the left common carotid artery due to the patient's anatomy being tortuous.Attempts were made to re-sheath the filter for repositioning, and the handle broke.Re-sheathing was unsuccessful.The distal filter was not able to be recaptured.The entire device was retrieved without difficulties or injury to the patient.The procedure proceeded without use of a sentinel cerebral protection system.
 
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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 Key9220998
MDR Text Key167216965
Report Number2134265-2019-12161
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 12/16/2019
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 Manufacturer10/09/2019
Initial Date Manufacturer Received 09/23/2019
Initial Date FDA Received10/22/2019
Supplement Dates Manufacturer Received12/06/2019
Supplement Dates FDA Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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