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

Model Number	OLH
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/29/2022
Type of Reportable Event	Death
Event or Problem 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.
Additional 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 "
• Common Device Name: "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
• Report Number: 3011706110-2022-00012
• Device Sequence Number: 14779616
• Product Code: OCL
• UDI-Device Identifier: 10840143904110
• UDI-Public: 10840143904110
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K210477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2025
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Sex: Female