SENTINEL CEREBRAL PROTECTION SYSTEM (US) CMS15-10C-US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-27 for SENTINEL CEREBRAL PROTECTION SYSTEM (US) CMS15-10C-US manufactured by Claret Medical, Inc..

Event Text Entries

[178378130] It was reported that proximal filter didn't retract. A sentinel cerebral protection system was successfully used for a procedure. During removal of the device, the number one slider was unable to resheath the proximal filter. The physician attempted to retract the slider several times without success. The distal filter was fully resheathed without issue. The sentinel device was removed with the proximal filter out. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-00472
MDR Report Key9633435
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-27
Date of Report2020-01-27
Date of Event2019-12-15
Date Mfgr Received2020-01-10
Date Added to Maude2020-01-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1CLARET MANUFACTURING
Manufacturer Street1745 COPPERHILL PARKWAY
Manufacturer CitySANTA ROSA CA 95403
Manufacturer CountryUS
Manufacturer Postal Code95403
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSENTINEL CEREBRAL PROTECTION SYSTEM (US)
Generic NameEMBOLIC PROTECTION DEVICE
Product CodePUM
Date Received2020-01-27
Model NumberCMS15-10C-US
Catalog NumberCMS15-10C-US
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCLARET MEDICAL, INC.
Manufacturer Address1745 COPPERHILL PARKWAY SANTA ROSA CA 95403 US 95403


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-27

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