MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR TRANSPOLAR PEN

Model Number MAX3

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

Patient Problem Cardiac Perforation (2513)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation but a device history review was obtained for lot number 78993.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

It was reported on 06-aug-2018, that a (b)(6) male patient underwent a mvp/cabg/full maze procedure ((b)(6) 2018) using oll2 and max3 devices.Immediately after tricuspid valve annulus ablation was performed from endocardium side by using max3, the patient¿s tissue was damaged with a ¿pop¿.The doctor continued the operation with no concern for that.At the time of ventilator weaning, a bleeding was observed.Therefore, the patient was put on the pump again and the bleeding site was repaired by suturing.It was undetermined whether a transfusion was utilized.The procedure prolonged approximately one hour.Currently, the patient is in stable condition.

• Brand Name: ISOLATOR TRANSPOLAR PEN
• Type of Device: ISOLATOR TRANSPOLAR PEN
• 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 ; 5137554563
• MDR Report Key: 7812664
• MDR Text Key: 118116726
• Report Number: 3011706110-2018-00204
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061593
• 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: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: MAX3
• Device Catalogue Number: A000218-JP
• Device Lot Number: 78993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2017
• 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: OLL2
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 68 YR