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 Cardiac Perforation (2513)

Event Date 02/01/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022 a (b)(6) male underwent a cabg with surgical ablation procedure.Extensive dissection was made to prepare for the encompass clamp, including manual dissection behind the svc and ivc.The guide was placed without difficulty.Once placed into the chest, the clamp was opened, with the tips oriented towards the left shoulder.Resistance was met and the surgeon verbalized that he wasn¿t forcing the clamp.Some additional effort was made from the right side, but ultimately the clamp was removed.The surgeon noted a small hole at the junction of the ivc/ra.The injury was closed with a single pledgeted suture, and an additional pledgeted suture was added to reinforce the repair.In follow-up conversation, the surgeon commented that overall tissue integrity was poor.The patient was doing well postoperatively.This is a procedural complication and there was no reported device malfunction.

Manufacturer Narrative

(b)(4).The olh device, lot number p135e, was returned for evaluation and visually and functionally tested.Device met all specifications as evaluated.Could not confirm complaint.

• 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: 13662221
• MDR Text Key: 287563343
• Report Number: 3011706110-2022-00005
• 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: 03/03/2022

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 Expiration Date: 06/01/2024
• Device Model Number: OLH
• Device Catalogue Number: A001143
• Device Lot Number: P1350E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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
• Treatment: ACHV50.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male