MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR ENCOMPASS ABLATION SYSTEM, GLIDEPATH MAGNETIC GUIDE

Model Number OLH

Device Problem Positioning Problem (3009)

Patient Problem Cardiac Perforation (2513)

Event Date 02/27/2023

Event Type  Injury  

Manufacturer Narrative

Case(b)(4).The device was not returned for investigation and no device malfunction was alleged.The device was not returned for investigation and a device history record review was unable to be conducted as the lot number for the device was not reported or able to be ascertained.

Event Description

On (b)(6) 2023 a 63-year-old female patient with thin cardiac tissue, underwent septal myectomy procedure with concomitant posterior wall encircling ablation using encompass clamp (olh).As surgeon was attempting to place clamp through the sinuses bleeding was observed.A minor perforation to distal left atrium noted.Surgeon arrested patient¿s heart and placed two stitches to successfully repair the small perforation.There were no further complications during surgical procedure.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ISOLATOR ENCOMPASS ABLATION SYSTEM, GLIDEPATH MAGNETIC GUIDE
• Type of Device: ISOLATOR ENCOMPASS ABLATION SYSTEM, GLIDEPATH MAGNETIC 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: 16622294
• MDR Text Key: 312116312
• Report Number: 3011706110-2023-00012
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• 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: 02/27/2023
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female