THERMOCOOL? SMART TOUCH? SF BI-DIRECTIONAL NAVIGATION CATHETER D134805

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 2020-03-30 for THERMOCOOL? SMART TOUCH? SF BI-DIRECTIONAL NAVIGATION CATHETER D134805 manufactured by Biosense Webster Inc.

MAUDE Entry Details

Report Number2029046-2020-00501
MDR Report Key9900642
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-30
Date of Report2020-03-09
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-10-18
Date Added to Maude2020-03-30
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 NameTHERMOCOOL? SMART TOUCH? SF BI-DIRECTIONAL NAVIGATION CATHETER
Generic NameCARDIAC ABLATION PERCUTANEOUS CATHETER
Product CodeLPB
Date Received2020-03-30
Returned To Mfg2020-03-23
Model NumberD134805
Catalog NumberD134805
Lot Number30303887M
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2020-03-30

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