FG GATEWAY MR JP 2.50MM X 9MM M0032072109250

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 2015-12-30 for FG GATEWAY MR JP 2.50MM X 9MM M0032072109250 manufactured by Boston Scientific - Minn.

Event Text Entries

[34734343] The subject device is not available.
Patient Sequence No: 1, Text Type: N, H10


[34734344] It was reported in a post market surveillance case that thrombectomy with the retriever was performed for a cardiogenic occlusion in the basilar artery. The artery did not recanalize. Angioplasty was done with the subject device and hydrocephalus due to intracranial hemorrhage occurred. Cerebral ventricle drainage was performed but the patient died.
Patient Sequence No: 1, Text Type: D, B5


[39036684] The device history record review could not be performed because the lot number of the device is not known. The device was not returned for analysis therefore visual inspection and functional testing could not be performed. From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event. Patient hemorrhage and death are known and anticipated complications to these types of procedures and are noted in the labeling. Therefore, it was determined that the reported event was an anticipated procedural complication.
Patient Sequence No: 1, Text Type: N, H10


[39036725] It was reported in a post market surveillance case that thrombectomy with the retriever was performed for a cardiogenic occlusion in the basilar artery. The artery did not recanalize. Angioplasty was done with the subject device and hydrocephalus due to intracranial hemorrhage occurred. Cerebral ventricle drainage was performed but the patient died.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008853977-2015-00553
MDR Report Key5336719
Report SourceHEALTH PROFESSIONAL
Date Received2015-12-30
Date of Report2015-12-07
Date of Event2012-04-13
Date Mfgr Received2016-01-28
Date Added to Maude2015-12-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. SANDA DRACIC
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 MR JP 2.50MM X 9MM
Generic NameCATHETER, BALLOON TYPE
Product CodePAV
Date Received2015-12-30
Catalog NumberM0032072109250
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - MINN
Manufacturer AddressONE SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Other; 3. Required No Informationntervention 2015-12-30

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