CELSIUS? ELECTROPHYSIOLOGY CATHETER D7TCDL252RT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for CELSIUS? ELECTROPHYSIOLOGY CATHETER D7TCDL252RT manufactured by Biosense Webster Inc.

MAUDE Entry Details

Report Number2029046-2020-00499
MDR Report Key9908864
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-04
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-31
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 NameCELSIUS? ELECTROPHYSIOLOGY CATHETER
Generic NameELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
Product CodeLPB
Date Received2020-03-31
Model NumberD7TCDL252RT
Catalog NumberD7TCDL252RT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOSENSE WEBSTER INC
Manufacturer Address33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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