MAUDE Adverse Event Report: MEDTRONIC, INC. AFFERA; PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH

Model Number	AFR-00001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the afr-00001 sphere 9 catheter with lot 0230018836 was returned and analyzed.The catheter was visually ins pected and functionally tested.The cirris shorts and mapping test was performed on this catheter and showed an open p2 and p4 electrode.A multimeter and breakout fixture was used to check for shorts to the metal braid, but none were found.During the mapping test, when trying to probe the p2 electrode, it was found that the p2 electrode was missing entirely from the lattice.The p4 electrode was seen having damaged wires on the back of the electrode.Dissection of the catheter included cutting the wires from the p4 electrode and testing for continuity in them.There was continuity in both of the wires when tested with a multimeter.Both of the open circuits were in zone 1 of the catheter.In conclusion, the catheter failed the returned product inspection due to a missing p2 electrode from the lattice.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during an atrial fibrillation ablation procedure, a catheter temperature sensor fault occurred, with one of the temperature sensors being out of range.This led to a pulsed field delivery error and an error message being displayed, temporarily interrupting the procedure.It was noted that the transeptal approach was challenging due to an aneurysmal septum, and the catheter was exchanged through another manufacturer's sheath several times.Connections were checked, and ultimately, a new catheter was used to successfully complete the procedure.No further issues were experienced after the catheter was replaced.The case was completed.No patient complications have been reported as a result of this event.

• Brand Name: AFFERA
• Common Device Name: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH
• Manufacturer (Section D): MEDTRONIC, INC.; 880 technology park drive; billerica MA 01821
• Manufacturer (Section G): MEDTRONIC, INC.; 880 technology park drive; billerica MA 01821
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21959877
• Report Number: 3012520654-2025-00047
• Device Sequence Number: 20649459
• Product Code: QZI
• UDI-Device Identifier: 00763000871741
• UDI-Public: 00763000871741
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P240013
• 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
• Report Date (Section B): 05/05/2025

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: 12/08/2025
• Device Model Number: AFR-00001
• Device Catalogue Number: AFR-00001
• Device Lot Number: 0230018836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female