DRAGONFLY? OPTIS? KIT BOX IMAGING CATHETER C408646

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-28 for DRAGONFLY? OPTIS? KIT BOX IMAGING CATHETER C408646 manufactured by St. Jude Medical Catd.

Event Text Entries

[188861714] The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3009600098-2020-00007
MDR Report Key9768987
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-28
Date of Report2020-03-26
Date of Event2020-02-11
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-12-02
Date Added to Maude2020-02-28
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 ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL CATD
Manufacturer Street4 ROBBINS DRIVE
Manufacturer CityWESTFORD MA 01886
Manufacturer CountryUS
Manufacturer Postal Code01886
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDRAGONFLY? OPTIS? KIT BOX IMAGING CATHETER
Generic NameCATHETER, INTRAVASCULAR, DIAGNOSTIC
Product CodeDQO
Date Received2020-02-28
Model NumberC408646
Catalog NumberC408646
Lot Number7278523
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL CATD
Manufacturer Address4 ROBBINS DRIVE WESTFORD MA 01886 US 01886


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-28

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