OUTBACK ELITE 120CM RE-ENTRY OTB59120A

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 2020-02-13 for OUTBACK ELITE 120CM RE-ENTRY OTB59120A manufactured by Cordis Corporation.

MAUDE Entry Details

Report Number9616099-2020-03521
MDR Report Key9707381
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-13
Date of Report2020-03-17
Date of Event2020-01-15
Date Mfgr Received2020-02-16
Device Manufacturer Date2018-03-26
Date Added to Maude2020-02-13
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 NameOUTBACK ELITE 120CM RE-ENTRY
Generic NameCATHETER FOR CROSSING TOTAL OCCLUSIONS
Product CodePDU
Date Received2020-02-13
Model NumberOTB59120A
Catalog NumberOTB59120A
Lot Number17765317
Device Expiration Date2020-02-29
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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
101. Required No Informationntervention 2020-02-13

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