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 2020-02-19 for SENTINEL CEREBRAL PROTECTION SYSTEM (US) CMS15-10C-US manufactured by Claret Medical, Inc..

Event Text Entries

[180394946] It was reported that the distal filter was unable to be recaptured. A sentinel cerebral protection system was selected for a transcatheter aortic valve replacement (tavr) procedure. When recapturing the distal filter, the handle number 3 separated from the device and it fractured off. The team proceeded to extract the device without capturing the distal filter. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-01666
MDR Report Key9726780
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-19
Date of Report2020-02-19
Date of Event2020-01-28
Date Mfgr Received2020-01-28
Device Manufacturer Date2019-08-27
Date Added to Maude2020-02-19
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 G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street160 KNOWLES DRIVE
Manufacturer CityLOS GATOS CA 95032
Manufacturer CountryUS
Manufacturer Postal Code95032
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 Received2020-02-19
Model NumberCMS15-10C-US
Catalog NumberCMS15-10C-US
Lot Number19J05H17
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 2020-02-19

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