SI AVANTI + 11F STD W/GW 504611X

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 2019-11-05 for SI AVANTI + 11F STD W/GW 504611X manufactured by Cordis Corporation.

MAUDE Entry Details

Report Number9616099-2019-03331
MDR Report Key9280470
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-05
Date of Report2019-11-05
Date of Event2019-10-11
Date Mfgr Received2019-10-11
Device Manufacturer Date2019-03-19
Date Added to Maude2019-11-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactKARLA CASTRO
Manufacturer Street14201 NW 60TH AVE
Manufacturer CityMIAMI LAKES FL 33014
Manufacturer CountryUS
Manufacturer Postal33014
Manufacturer Phone7863138372
Manufacturer G1CORDIS CORPORATION
Manufacturer Street14201 NW 60TH AVE
Manufacturer CityMIAMI LAKES FL 33014
Manufacturer CountryUS
Manufacturer Postal Code33014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSI AVANTI + 11F STD W/GW
Generic NameDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Product CodeDRE
Date Received2019-11-05
Returned To Mfg2019-11-15
Model Number504611X
Catalog Number504611X
Lot Number17846523
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCORDIS CORPORATION
Manufacturer Address14201 NW 60 AVENUE MIAMI LAKES FL 33014 US 33014


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-05

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