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 07/28/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 an 80-year-old male patient underwent an on-pump coronary artery bypass graft (cabg) procedure with surgical ablation and left atrial appendage (laa) exclusion.While positioning the clamp, a hole was made in the right anterior veins near the vein bifurcation.The hole was fixed with one stitch and one pledget.Physician aborted the ablation due to the surrounding tissue condition and proceeded to manage the laa with an achv clip.Post procedure the patient was recovering.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

Manufacturer Narrative

(b)(4) the device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the olh device was not reported or able to be subsequently ascertained.

• 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: 15306706
• MDR Text Key: 298766555
• Report Number: 3011706110-2022-00029
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• 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: A001143
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: No
• 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: ATRICLIP
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male