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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2018
Event Type  malfunction  
Event Description
It was reported that the filter did not collapse.A sentinel cerebral protection system was in use during a transcatheter aortic valve replacement procedure.Upon removal of the sentinel device, the proximal basket failed to re-sheath.The device was pulled out with the filter deployed.There was no patient injury and the patient status is fine.
 
Manufacturer Narrative
Device eval by manufacturer: as per visual inspection, the hypotube was bent.The device was received with the introducer sheath still on the device and the proximal filter is inside the introducer sheath.A compression area was observed in the transition area of the outer sheath.The handles are separated 5cm.As per functional inspection, #3 hub does not flush.
 
Event Description
It was reported that the filter did not collapse.A sentinel cerebral protection system was in use during a transcatheter aortic valve replacement procedure.Upon removal of the sentinel device, the proximal basket failed to re-sheath.The device was pulled out with the filter deployed.There was no patient injury and the patient status is fine.
 
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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 Key8228420
MDR Text Key132424296
Report Number2134265-2019-00013
Device Sequence Number1
Product Code PUM
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 03/27/2019
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 Expiration Date11/30/2020
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number18L27H17
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2019
Initial Date Manufacturer Received 12/21/2018
Initial Date FDA Received01/08/2019
Supplement Dates Manufacturer Received03/06/2019
Supplement Dates FDA Received03/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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