FG GATEWAY OTW OUS 2.00MM X 9MM M0032072409200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-04 for FG GATEWAY OTW OUS 2.00MM X 9MM M0032072409200 manufactured by Boston Scientific - Minn.

MAUDE Entry Details

Report Number3008853977-2019-00045
MDR Report Key8668996
Report SourceHEALTH PROFESSIONAL
Date Received2019-06-04
Date of Report2019-08-02
Date of Event2019-05-09
Date Mfgr Received2019-07-15
Device Manufacturer Date2018-12-06
Date Added to Maude2019-06-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. TARA LOPEZ
Manufacturer Street47900 BAYSIDE PARKWAY
Manufacturer CityFREMONT CA 94538
Manufacturer CountryUS
Manufacturer Postal94538
Manufacturer Phone5104132500
Manufacturer G1BOSTON SCIENTIFIC - MINN
Manufacturer StreetONE SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal Code55311
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFG GATEWAY OTW OUS 2.00MM X 9MM
Generic NameCATHETER, BALLOON TYPE
Product CodeGBA
Date Received2019-06-04
Returned To Mfg2019-06-07
Catalog NumberM0032072409200
Lot Number23030533
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - MINN
Manufacturer AddressONE SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-04

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