MAUDE Adverse Event Report: ATRICURE, INC. COBRA® FUSION® 150 ABLATION MINIMALLY INVASIVE SYSTEM

Model Number COBRA FUSION 150 ABLATION MININALLY INVASIVE SYSTEM

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b))(4).The device was returned for evaluation.The device was visually and functionally tested.The complaint was confirmed.Visual inspection confirmed that an electrode tang from electrode #1 was detached from the device.The electrical inspection failed due to the missing electrode.The broken piece was returned with device return.Although the electrode tang was not present, lesions were able to be made.

Event Description

It was reported that on (b)(6) 2019 a patient underwent an off-pump ablation procedure using the cobra fusion 150.After the first ablation the generator gave an error message, the device was removed and the visual check confirmed that electrode number 1 was broken.A new device was used to complete the procedure.There was no adverse consequence and the patient left hospital in sinus rhythm.

• Brand Name: COBRA® FUSION® 150 ABLATION MINIMALLY INVASIVE SYSTEM
• Type of Device: COBRA® FUSION® 150 ABLATION MINIMALLY INVASIVE SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 9565271
• MDR Text Key: 193930226
• Report Number: 3011706110-2020-00001
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: COBRA FUSION 150 ABLATION MININALLY INVASIVE SYSTEM
• Device Catalogue Number: 001-700-001MI
• Device Lot Number: 92858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1