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 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - the device was returned for investigation.The complaint was confirmed.The red rubber was found to have fractured.Visual inspection, load testing, and inspection of red rubber cross-section did not lead to discovery of any non-conformance.

Event Description

On (b)(6) 2023, a 75-year-old male patient underwent a coronary artery bypass graft with concomitant posterior wall encircling ablation.During the encompass clamp ablation the physician attempted to remove the gpm100 glidepath tape prior to ablation.When removing the glidepath tape with clamp in place, the magnet end snapped off from the red rubber and stayed magnetized to the clamp.Procedure was completed with no harm to the patient.

Event Description

A patient underwent an on-pump coronary artery bypass graft procedure via median sternotomy with concomitant posterior wall encircling ablation utilizing the encompass clamp.When removing the glidepath tape, it was observed that the gpm100 red rubber was fractured at the connection point to the magnetic tip.There was no reported serious injury to the patient during the procedure.If this malfunction were to recur, it may have the potential to cause or contribute to a serious injury.

• 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 ; mason, OH 45040 ; 5136448220
• MDR Report Key: 17147757
• MDR Text Key: 317355571
• Report Number: 3011706110-2023-00024
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 30840143903377
• UDI-Public: (01)30840143903377(17)240801(10)P1401C
• 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,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• 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
• Device Lot Number: P1401C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLH
• Patient Age: 75 YR
• Patient Sex: Male