FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

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 2019-05-03 for FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM manufactured by Boston Scientific Corporation.

Event Text Entries

[143970157] It was reported that the device became stuck on the wire. A filterwire embolic protection system and jetstream atherectomy catheter were selected for use during a atherectomy procedure in the superficial femoral artery (sfa). While the devices were near the adductor canal it became stuck to each other. The devices were removed together. The procedure was completed with a balloon. There was no consequence to the patient, and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2019-04781
MDR Report Key8577720
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-03
Date of Report2019-05-03
Date of Event2019-03-29
Date Mfgr Received2019-04-12
Date Added to Maude2019-05-03
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 ContactSONALI ARANGIL
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone6515827403
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street2546 FIRST STREET, PROPARK
Manufacturer CityEL COYOL ALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
Generic NameTEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
Product CodeNFA
Date Received2019-05-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-03

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