MAUDE Adverse Event Report: ATRICURE, INC. "ISOLATOR SYNERGY"" ENCOMPASS CLAMP AND GUIDE "

Model Number OLH

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

Patient Problem Perforation (2001)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon receipt, the olh clamp, lot number p1350b, was visually and functionally inspected pursuant to specific atricure investigation procedures.The complaint was not confirmed, device met specifications.

Event Description

It was reported on (b)(6) 2021 that a patient underwent a coronary artery bypass and rf ablation procedure.The physician was doing the rf ablation with the olh device and noted a 1cm tear to the left atrium at the insertion point underneath the superior vena cava that the physician closed with prolene sutures.The ablation procedure was then completed, followed by a concomitant cabg procedure.The patient was stable post procedure.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: "ISOLATOR SYNERGY"" ENCOMPASS CLAMP AND GUIDE "
• Type of Device: "ISOLATOR SYNERGY"" ENCOMPASS CLAMP AND GUIDE "
• 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 innovaton way; mason, OH 45040 ; 5136448220
• MDR Report Key: 12707301
• MDR Text Key: 278759009
• Report Number: 3011706110-2021-00047
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: OLH
• Device Catalogue Number: A001143
• Device Lot Number: P1350B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention