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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 07/14/2020
Event Type  malfunction  
Event Description
It was reported that an inability to resheath the proximal filter occurred.A sentinel cerebral protection device was successfully placed inside the patient.Upon retrieval of the device, it was noted that proximal filter slider would only move half of travel distance.The proximal filter was partially constrained.The sentinel catheter was withdrawn via the sheath with the proximal filter partially deployed.No patient complications were reported.
 
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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)
BOSTON SCIENTIFIC CORPORATION
160 knowles drive
los gatos CA 95032
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10379642
MDR Text Key202043249
Report Number2134265-2020-10718
Device Sequence Number1
Product Code PUM
UDI-Device Identifier00863229000004
UDI-Public00863229000004
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 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/27/2022
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0025119281
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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