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 10/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The olh device was not returned for evaluation, but a device history review was obtained for lot number p1350b.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

It was reported that on (b)(6) 2021 a (b)(6) male patient with a history of (b)(6) underwent an (b)(6 replacement and (b)(6) procedure.While using the encompass (olh) clamp the physician attempted to follow the guide rubber into place and each time was met with resistance.Physician ultimately opted not to use the olh.Surgeon then used alternative devices, and the procedure was completed.When patient was coming off of (b)(6) a perforation of the (b)(6) just below the right (b)(6) was discovered.Surgeon repaired the perforation with a running suture and the patient was stable post procedure.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: 12863819
• MDR Text Key: 284710907
• Report Number: 3011706110-2021-00051
• 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: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: OLH
• Device Catalogue Number: A0001143
• Device Lot Number: P1350B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OSL2, CRYO3.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 73
• Patient Sex: Male
• Patient Weight: 94 KG