MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE BIPOLAR SYSTEM

Model Number EML2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) the eml2 device has not been returned for evaluation.Once returned and investigated, a supplemental report will be submitted.

Event Description

It was reported that on (b)(6) 2021 a patient underwent a wolf-ohtsuka ablation procedure with left atrial appendage (laa) occlusion.After laa excision, a mid1 was used to complete the dissection.When surgeon started to ablate left pulmonary vein using the eml2, bleeding was observed from posterior wall of the left atrium.Once the bleeding was controlled, the procedure was completed.Post procedure, the patient is recovering.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ATRICURE BIPOLAR SYSTEM
• Type of Device: ATRICURE BIPOLAR 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: 11272529
• MDR Text Key: 230057127
• Report Number: 3011706110-2021-00004
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: EML2
• Device Catalogue Number: A000467-JP
• Device Lot Number: 104678
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2020
• 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
• Treatment: MID1
• Patient Outcome(s): Life Threatening