PROPLEGE CORONARY SINUS CATHETER MODEL PR9

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-02 for PROPLEGE CORONARY SINUS CATHETER MODEL PR9 manufactured by Edwards Lifesciences.

MAUDE Entry Details

Report Number3008500478-2020-00182
MDR Report Key9539338
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-02
Date of Report2019-12-09
Date of Event2019-12-06
Date Mfgr Received2019-12-09
Date Added to Maude2020-01-02
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 ContactMS. AMRITHA SRINIVASAN
Manufacturer StreetONE EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492504062
Manufacturer G1EDWARDS LIFESCIENCES LLC
Manufacturer StreetONE EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROPLEGE CORONARY SINUS CATHETER MODEL PR9
Generic NameCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Product CodeDWF
Date Received2020-01-02
Returned To Mfg2020-01-10
Model NumberPR9
Catalog NumberPR9
Lot Number62487643
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES
Manufacturer AddressONE EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-02

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