SPIDER FX SPD2-US-060-320

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 2019-04-17 for SPIDER FX SPD2-US-060-320 manufactured by Covidien.

Event Text Entries

[142506710] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[142506711] The physician was intending to use a 6mm spider during treatment. A 6fr sheath was used in the procedure and the ifu was followed. It was reported that the catheter broke in half and another product was used to complete the procedure. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183870-2019-00176
MDR Report Key8522516
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-17
Date of Report2019-07-09
Date of Event2019-04-12
Date Mfgr Received2019-07-08
Device Manufacturer Date2019-03-06
Date Added to Maude2019-04-17
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 ContactTONI O'DOHERTY
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer Phone091708734
Manufacturer G1COVIDIEN
Manufacturer Street4600 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPIDER FX
Generic NameDEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC
Product CodeNFA
Date Received2019-04-17
Returned To Mfg2019-06-04
Catalog NumberSPD2-US-060-320
Lot NumberA794271
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address4600 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-17

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