FAST-CATH? TRANSSEPTAL GUIDING INTRODUCER SWARTZ? SL TRANSSEPTAL SERIES, SL1? 8. 406849

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for FAST-CATH? TRANSSEPTAL GUIDING INTRODUCER SWARTZ? SL TRANSSEPTAL SERIES, SL1? 8. 406849 manufactured by St. Jude Medical.

MAUDE Entry Details

Report Number3005334138-2020-00136
MDR Report Key9885539
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2019-12-26
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-06-29
Date Added to Maude2020-03-26
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, SL1? 8.
Generic NameINTRODUCER, CATHETER
Product CodeDYB
Date Received2020-03-26
Returned To Mfg2020-03-04
Model Number406849
Catalog Number406849
Lot Number7068790
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL
Manufacturer Address5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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