MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR SYNERGY ACCESS CLAMP

Model Number EMT1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Great Vessel Perforation (2152)

Event Date 06/08/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2022 a patient underwent a mitral valve replacement with surgical ablation.Surgeon completed the right pulmonary vein isolation and dissected the left veins with an instrument clamp.The emt1 device was used to maneuver around the veins but before clamping down, bleeding was observed on the anterior aspect of the left inferior pulmonary vein.The injury was repaired with sutures from both outside and inside the atrium.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ISOLATOR SYNERGY ACCESS CLAMP
• Type of Device: ISOLATOR SYNERGY ACCESS CLAMP
• 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: 14932368
• MDR Text Key: 295341292
• Report Number: 3011706110-2022-00023
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110117
• 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: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EMT1
• Device Catalogue Number: A000602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• 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
• Patient Outcome(s): Required Intervention; Life Threatening