SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PE074F5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-14 for SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PE074F5 manufactured by Edwards Lifesciences, Pr.

MAUDE Entry Details

Report Number2015691-2019-03777
MDR Report Key9187527
Date Received2019-10-14
Date of Report2019-09-20
Date of Event2019-09-20
Date Mfgr Received2019-09-20
Device Manufacturer Date2019-03-30
Date Added to Maude2019-10-14
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. JESSICA ATALLAH
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492500249
Manufacturer G1EDWARDS LIFESCIENCES, PR
Manufacturer StreetSTATE RD INDUS PK 402 KM 1.4
Manufacturer CityANASCO PR 00610
Manufacturer CountryUS
Manufacturer Postal Code00610
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
Generic NamePACING CATHETER
Product CodeLDF
Date Received2019-10-14
Returned To Mfg2019-09-30
Model NumberPE074F5
Lot Number62064160
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES, PR
Manufacturer AddressSTATE RD INDUS PK 402 KM 1.4 ANASCO PR 00610 US 00610


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-14

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