FAST-CATH? TRANSSEPTAL GUIDING INTRODUCER SWARTZ? SL TRANSSEPTAL SERIES 63 CM LE 406840

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-30 for FAST-CATH? TRANSSEPTAL GUIDING INTRODUCER SWARTZ? SL TRANSSEPTAL SERIES 63 CM LE 406840 manufactured by St. Jude Medical.

MAUDE Entry Details

Report Number3005334138-2019-00646
MDR Report Key9392263
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-30
Date of Report2019-11-30
Date of Event2019-11-05
Date Mfgr Received2019-11-05
Device Manufacturer Date2019-08-07
Date Added to Maude2019-11-30
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 ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL (AFD-PLYMOUTH)
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFAST-CATH? TRANSSEPTAL GUIDING INTRODUCER SWARTZ? SL TRANSSEPTAL SERIES 63 CM LE
Generic NameINTRODUCER, CATHETER
Product CodeDYB
Date Received2019-11-30
Model Number406840
Lot Number7124163
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL
Manufacturer Address5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-30

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