FILTERWIRE EZ 44150

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-03-04 for FILTERWIRE EZ 44150 manufactured by Boston Scientific Corporation.

Event Text Entries

[137705819] Age at time of event: 18 years or older.
Patient Sequence No: 1, Text Type: N, H10


[137705820] It was reported that the filterwire broke and had to be removed with snare. The target lesion was located in the non-calcified carotid artery which had a significant bend. A 190cm filterwire ez was selected for use. During withdrawal resistance was encountered. It was then noted that the device broke. Consequently, the whole system was removed with the help of a snaring device. The procedure was completed with another device. No further patient complications were reported and the patient's status was stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2019-01902
MDR Report Key8386743
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-03-04
Date of Report2019-03-04
Date of Event2019-02-11
Date Mfgr Received2019-02-11
Date Added to Maude2019-03-04
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 DE COSTA RICA S.R.L.
Manufacturer Street2546 CALLE PRIMERA PROPARK, COYOL
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFILTERWIRE EZ
Generic NameTEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
Product CodeNFA
Date Received2019-03-04
Model Number44150
Catalog Number44150
Lot Number21184538
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
101. Required No Informationntervention 2019-03-04

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