SENTINEL 008632290000004 CMS15-10C-US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for SENTINEL 008632290000004 CMS15-10C-US manufactured by Claret Medical, Inc..

Event Text Entries

[177167916] Could not feed sentinel device on the wire, several attempts were made but it still would not get the wire down. A new device was used and worked fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9653029
MDR Report Key9653029
Date Received2020-01-31
Date of Report2019-12-19
Date of Event2019-12-17
Report Date2019-12-20
Date Reported to FDA2019-12-20
Date Reported to Mfgr2020-01-31
Date Added to Maude2020-01-31
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSENTINEL
Generic NameTEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES
Product CodePUM
Date Received2020-01-31
Model Number008632290000004
Catalog NumberCMS15-10C-US
Lot Number19J05H17
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCLARET MEDICAL, INC.
Manufacturer Address1745 COPPERHILL PARKWAY SANTA ROSA CA 95403 US 95403


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-31

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