FILTERWIRE EZ 7576

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 2019-04-23 for FILTERWIRE EZ 7576 manufactured by Boston Scientific Corporation.

Event Text Entries

[142792921] It was reported that the shaft broke. A 190cm filterwire ez was selected for use. During preparation, it was noted that the shaft was broken as the components came apart. When unpacking, the shaft was not noted to be broken. The procedure was completed with another of the same device. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2019-04222
MDR Report Key8540885
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-23
Date of Report2019-05-24
Date of Event2019-04-01
Date Mfgr Received2019-05-10
Device Manufacturer Date2017-12-18
Date Added to Maude2019-04-23
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 Received2019-04-23
Returned To Mfg2019-04-11
Model Number7576
Catalog Number7576
Lot Number0021526912
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-23

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