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

Model Number	GPM100
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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
• Common Device Name: 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
• Report Number: 3011706110-2023-00024
• Device Sequence Number: 12160076
• Product Code: OCL
• UDI-Device Identifier: 30840143903377
• UDI-Public: (01)30840143903377(17)240801(10)P1401C
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLH
• Patient Age: 75 YR
• Patient Sex: Male