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

Model Number EMR2

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

Patient Problem Pulmonary Embolism (1498)

Event Type  Injury  

Manufacturer Narrative

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 device was not reported or able to be subsequently ascertained.

Event Description

On (b)(6) 2023 a female patient underwent a hybrid sinus node sparing ablation procedure for inappropriate sinus tachycardia using an emr2.Sometime post operatively patient was readmitted to the hospital with a pulmonary embolism requiring interventional radiology treatment to remove.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: 18298219
• MDR Text Key: 330112601
• Report Number: 3011706110-2023-00052
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EMR2
• Device Catalogue Number: A000452
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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, MLP1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female