MAUDE Adverse Event Report: ATRICURE, INC. MAGNETIC GLIDE PATH TAPE

Model Number GPM100

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the gpm100 was returned for investigation and the complaint was confirmed.The end of the device that did not fail remained intact to a load well past specification when tested.There was no evidence of a manufacturing cause.There was no manufacturing defect nor component malfunction identified.

Event Description

A patient underwent a coronary artery bypass graft via median sternotomy with posterior wall encircling ablation using an encompass clamp.The procedure was completed successfully.As the surgeon removed the clamp from the chest, one of the magnets was not present.The magnet was located in the chest and was retrieved using a metal instrument.There was no reported patient harm.

• Brand Name: MAGNETIC GLIDE PATH TAPE
• Type of Device: MAGNETIC GLIDE PATH TAPE
• 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: 18808549
• MDR Text Key: 337626556
• Report Number: 3011706110-2024-00017
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GPM100
• Device Catalogue Number: A001212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• 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