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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 11/14/2019
Event Type  malfunction  
Event Description
It was reported that the filter was unable to be recaptured.A sentinel cerebral protection system was advanced and deployed during a transaortic valve replacement procedure.Following valve implant, during an attempt to recapture the distal filter, the #3 handle broke off.The distal filter was unable to be re-sheathed.The filter was removed by removing the radial sheath and then removing the sentinel device.There was no patient harm or patient issues.
 
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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
Manufacturer (Section G)
CLARET MEDICAL, INC.
1745 copperhill parkway
suite 1
santa rosa CA 95403
UK   95403
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9427661
MDR Text Key175685746
Report Number2134265-2019-14765
Device Sequence Number1
Product Code PUM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DEN160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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