FLEXCATH ADVANCE STEERABLE SHEATH 4FC12

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 2020-03-11 for FLEXCATH ADVANCE STEERABLE SHEATH 4FC12 manufactured by Medtronic Cryocath Lp.

Event Text Entries

[183008968] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183008969] It was reported that post-operative to a successful cryo ablation procedure, the patient experienced "pericardial pain". The patient was treated with medication. The patient is a participant in a clinical study. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002648230-2020-00151
MDR Report Key9819546
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2018-10-12
Date Mfgr Received2020-02-21
Device Manufacturer Date2018-08-30
Date Added to Maude2020-03-11
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC CRYOCATH LP
Manufacturer Street9000 AUTOROUTE TRANSCANADIENNE
Manufacturer CityPOINTE-CLAIRE,QC H9R 5Z8
Manufacturer CountryCA
Manufacturer Postal CodeH9R 5Z8
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXCATH ADVANCE STEERABLE SHEATH
Generic NameCATHETER, STEERABLE
Product CodeDRA
Date Received2020-03-11
Model Number4FC12
Catalog Number4FC12
Lot Number92044
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC CRYOCATH LP
Manufacturer Address9000 AUTOROUTE TRANSCANADIENNE POINTE-CLAIRE,QC H9R 5Z8 CA H9R 5Z8


Patients

Patient NumberTreatmentOutcomeDate
121. Required No Informationntervention 2020-03-11

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