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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 Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2019
Event Type  malfunction  
Event Description
It was reported that the distal tip of the device broke off inside the patient.As the sentinel was moving through the brachial artery the distal tip of the device broke off inside the patient at the access site.The procedure ended after they got the tip of the device removed from the patient's body via snaring.No complications to patient.
 
Event Description
It was reported that the distal tip of the device broke off inside the patient.As the sentinel was moving through the brachial artery the distal tip of the device broke off inside the patient at the access site.The procedure ended after they got the tip of the device removed from the patient's body via snaring.No complications to patient.It was further reported that the sentinel embolic protection device was being used in a transcatheter aortic valve replacement (tavr) with lotus edge valve.There were no issues noted with the performance of the lotus edge valve.The device fragment was removed from the patient's arm and was associated with the sentinel embolic protection device.
 
Manufacturer Narrative
Analysis of returned product revealed that the guidewire was still inside the device, and the distal filter hypotube did not came back with the returned unit.Inner member was found kinked and its proximal section was detached.Distal filter deployment attempt could not be performed due to the condition in which the device was returned.Guidewire was removed from the device and it was noticed that its tip was unraveling.Articulating sheath was cut open and the tip was found still attached and inside the device.Product analysis could not confirmed the reported tip detachment.
 
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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 Key8789709
MDR Text Key151003307
Report Number2134265-2019-07973
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 10/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2021
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number19E21H24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2019
Date Manufacturer Received10/01/2019
Patient Sequence Number1
Patient Age61 YR
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