DIREXION HI-FLO FATHOM-16 SYSTEM 84591

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 2020-03-17 for DIREXION HI-FLO FATHOM-16 SYSTEM 84591 manufactured by Boston Scientific Corporation.

Event Text Entries

[183880857] It was reported that the catheter broke in half. A direxion hi-flo fathom-16 system was selected for use. During the procedure, it was noted that the catheter came apart and broke in half. The procedure was completed with another of the same device. No patient complications were reported and patient was fine post procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03332
MDR Report Key9841732
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-17
Date of Report2020-04-01
Date of Event2020-03-02
Date Mfgr Received2020-03-24
Device Manufacturer Date2019-12-09
Date Added to Maude2020-03-17
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 ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORK LIMITED
Manufacturer StreetMODEL FARM ROAD
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIREXION HI-FLO FATHOM-16 SYSTEM
Generic NameCATHETER, CONTINUOUS FLUSH
Product CodeKRA
Date Received2020-03-17
Model Number84591
Catalog Number84591
Lot Number0024897592
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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
10 2020-03-17

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