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 2020-03-23 for FILTERWIRE EZ 44150 manufactured by Boston Scientific Corporation.

Event Text Entries

[184496077] It was reported that there was difficulty retrieving the filter. The mildly tortuous stenosed target lesion was located in the mid and distal of right coronary artery (rca). After the physician delivered a 190 cm filterwire ez to the distal rca, a 4. 00x48mm synergy ii drug-eluting stent was deployed to the mid and distal of rca. Following stent deployment and post dilatation, the physician delivered retrieve sheath to pull back the filter wire but the sheath was unable to reach the filter. As the physician pulled back the wire, the deployed stent became deformed and the filter wire become stuck in the stent. Then, a 7fr guidezilla guide extension catheter was advanced to remove the filterwire but was unsuccessful. Finally, the patient was sent to surgery. Surgery was performed to remove the stent and the filterwire. Coronary artery bypass graft surgery was also completed. Post surgery, the patient was in stable condition.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03699
MDR Report Key9865906
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-03-18
Date Mfgr Received2020-03-18
Device Manufacturer Date2019-08-19
Date Added to Maude2020-03-23
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 ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street2546 CALLE PRIMERA
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 Received2020-03-23
Model Number44150
Catalog Number44150
Lot Number0024290802
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 2020-03-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.