ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362

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 2019-03-25 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..

Event Text Entries

[139695580] Case-(b)(4), the device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the oll2 device was not reported or able to be subsequently ascertained. The complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10


[139695581] It was reported by the surgeon that during one of his surgical procedures while ablating the junction where pulmonary vein meets the roof and/or the floor lesions when some bleeding was observed bleeding that may be been attributed to over burning from the oll2 device. Surgeon is theorizing that the point where lesions overlap the tissue may have? Broken down? And bled. Surgeon used a pledgetted suture to close the defect and the patient did well. This event is a procedure related complication, there was no reported device malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011706110-2019-00014
MDR Report Key8447957
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-03-25
Date of Report2019-03-25
Date Mfgr Received2019-02-25
Date Added to Maude2019-03-25
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 ContactMR. JOHN EHLERT
Manufacturer Street7555 INNOVATION WAY
Manufacturer CityMASON OH 45040
Manufacturer CountryUS
Manufacturer Postal45040
Manufacturer Phone5137554563
Manufacturer G1ATRICURE, INC.
Manufacturer Street7555 INNOVATION WAY
Manufacturer CityMASON OH 45040
Manufacturer CountryUS
Manufacturer Postal Code45040
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATRICURE SYNERGY ABLATION SYSTEM
Generic NameATRICURE SYNERGY ABLATION SYSTEM
Product CodeOCM
Date Received2019-03-25
Model NumberOLL2
Catalog NumberA000362
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerATRICURE, INC.
Manufacturer Address7555 INNOVATION WAY MASON OH 45040 US 45040


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2019-03-25

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