SENTINEL CEREBRAL PROTECTION DEVICE 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 2020-03-20 for SENTINEL CEREBRAL PROTECTION DEVICE CMS15-10C-US manufactured by Boston Scientific Corporation.

Event Text Entries

[184265779] During transcath aortic valve replacement percutaneous approach, a sentinel cerebral protection device leaked at the pressure port. A new replacement device was used instead and so no impact to patient. The device was saved and was picked up by the boston sci representative for return to boston sci for inspection of device that failed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9859583
MDR Report Key9859583
Date Received2020-03-20
Date of Report2020-03-06
Date of Event2020-02-25
Report Date2020-03-10
Date Reported to FDA2020-03-10
Date Reported to Mfgr2020-03-20
Date Added to Maude2020-03-20
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 CEREBRAL PROTECTION DEVICE
Generic NameTEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES
Product CodePUM
Date Received2020-03-20
Returned To Mfg2020-03-04
Model NumberCMS15-10C-US
Catalog NumberCMS15-10C-US
Lot Number25086338
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address1745 COPPERHILL PKWY SANTA ROSA CA 95403 US 95403


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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