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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 12/04/2019
Event Type  malfunction  
Event Description
It was reported that the distal filter would not recapture.A sentinel cerebral protection system was selected for use in a transcatheter aortic valve replacement (tavr) procedure.The sentinel device was deployed.When the physician attempted to retrieve the distal filter, it would not insert into the catheter.The physician pulled on the mechanism and the mechanism broke off prior to getting the filter back into the catheter.The filter was removed partially open.They completed the procedure with no other issues.There were no patient compilations.
 
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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
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9480608
MDR Text Key176485159
Report Number2134265-2019-15790
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 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
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 Received12/04/2019
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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