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

Model Number OLH

Device Problem Positioning Failure (1158)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888)

Event Date 03/29/2022

Event Type  Death  

Event Description

On (b)(6) 2022 a patient with a history of atrial fibrillation, hypertension, diabetes, and kidney disease underwent a 3-vessel coronary artery bypass graft (cabg) surgical procedure with concomitant rf ablation.After routing the encompass clamp, the physician lifted the heart to visualize the clamp jaw location but could not visualize the lower clamp jaw.Further inspection revealed an injury to the right inferior pulmonary vein which was repaired with 2-pledgeted sutures.That night, the patient showed signs and symptoms of a stroke.Ct testing confirmed an embolic stroke and patient ultimately expired on (b)(6) 2022.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.This was a procedural complication and there was no reported device malfunction.

Manufacturer Narrative

(b)(4).Upon receipt, the olh clamp, lot number 116767, was visually and functionally inspected pursuant to specific atricure investigation procedures.Device met all specifications and passed return evaluation checklist.Unable to confirm any non-conformities.

• 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: 14218670
• MDR Text Key: 290154545
• Report Number: 3011706110-2022-00012
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 10840143904110
• UDI-Public: 10840143904110
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• 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: A0001143
• Device Lot Number: 116767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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): Death
• Patient Age: 74 YR
• Patient Sex: Female