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 Stroke/CVA (1770)

Event Date 05/10/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 a patient underwent an on-pump, heparinized aortic valve, mitral valve, tricuspid valve, maze procedure using the encompass (olh) and cryo2 devices.When the left atrium was opened a very large clot clot was discovered that had not been identified by pre-op echo.The clot was removed, and the procedure continued as planned.The aorta was opened and additional pieces of clot were found in the aorta.Post-op patient suffered a stroke while still in the hospital.There is no confirmed causal link between the rf ablation and the stroke.Contribution from the rf ablation procedure cannot be ruled out, so this event is being reported per part 803.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

Manufacturer Narrative

(b)(4).The product history was reviewed for lot 118246.There is nothing in the product history record that would indicate that the devices were released with any non-conformances that would contribute to the reported event.

• 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 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 14718484
• MDR Text Key: 294941314
• Report Number: 3011706110-2022-00021
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2022

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 Model Number: OLH
• Device Catalogue Number: A001143
• Device Lot Number: 118246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CRYO2
• Patient Outcome(s): Life Threatening