PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER D128208

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-23 for PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER D128208 manufactured by Biosense Webster Inc..

MAUDE Entry Details

Report Number2029046-2020-00446
MDR Report Key9864132
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-23
Date of Report2020-02-26
Date of Event2020-02-26
Date Mfgr Received2020-02-26
Device Manufacturer Date2019-11-25
Date Added to Maude2020-03-23
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 ContactMR. GABRIEL ALFAGEME
Manufacturer Street31 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone949789-868
Manufacturer G1BIOSENSE WEBSTER INC (JUAREZ)
Manufacturer StreetCIRCUITO INTERIOR NORTE 1820PARQUE INDUSTRIAL SALVACAR
Manufacturer CityJUAREZ 32599
Manufacturer CountryMX
Manufacturer Postal Code32599
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
Generic NameCATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
Product CodeMTD
Date Received2020-03-23
Model NumberD128208
Catalog NumberD128208
Lot Number30326014L
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBIOSENSE WEBSTER INC.
Manufacturer Address33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2020-03-23

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