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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 Problem Difficult to Remove (1528)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 11/26/2019
Event Type  malfunction  
Event Description
It was reported that the proximal filter wouldn't retract.A sentinel cerebral protection system was selected for use.While pulling back on knob #1, only half of the proximal filter went into the catheter.No patient consequences were reported.
 
Event Description
It was reported that the proximal filter wouldn't retract.A sentinel cerebral protection system was selected for use.While pulling back on knob #1, only half of the proximal filter went into the catheter.No patient consequences were reported.It was further reported that the event occurred during prep and the device was never used in the patient.
 
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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 Key9461017
MDR Text Key176292863
Report Number2134265-2019-15342
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 01/15/2020
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 Expiration Date09/30/2021
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number19J23H18
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/27/2019
Initial Date FDA Received12/12/2019
Supplement Dates Manufacturer Received12/20/2019
Supplement Dates FDA Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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