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 06/16/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4) the olh clamp met all specifications and there were no design/manufacturing defects noted.

Event Description

On (b)(6) 2022 a 69-year-old male patient underwent an on-pump coronary artery bypass graft (cabg) procedure with concomitant surgical ablation.The physician encountered difficulty placing the clamp.Once the physician gained access to the sinuses with the magnetic guide system, the clamp was advanced.The physician could not see the tip of the clamp through the transverse sinus, so the clamp was removed and bleeding was discovered.The heart was arrested to repair the injury with sutures.Patient was recovering without complications post operatively.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 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 15026584
• MDR Text Key: 295955717
• Report Number: 3011706110-2022-00025
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 03084014390411
• UDI-Public: 3084014390411
• 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: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2022

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: 119371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 155 KG