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	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a cardiac ablation procedure, the catheter was removed from the body to clear a bubble alert, and upon removal, blood matter was noted on the lattice tip of the catheter.It was not possible to remove the blood matter by flushing through the pump or by manually cleaning the lattice.The catheter was replaced, and the case was completed.The activated clotting time (act) was above 350 seconds for the duration of the entire case and before the catheter entered the body.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the afr-00001 sphere9 catheter with lot 0229895508was returned and analyzed.During external visual inspection, the catheter was found to be intact, and a small amount of foreign material was seen attached to the tip of the lattice of the catheter.The cirris shorts and mapping test was performed on the catheter with passing results.A multimeter and breakout fixture was used to check for shorts to the metal braid, but none were found.The occlusion test was performed on the catheter using a leak tester and was found to have passing results.In conclusion, the reported "material in catheter tip" was confirmed through during visual inspection testing.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.

• 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: 21072072
• Report Number: 3012520654-2024-00007
• Device Sequence Number: 3409957
• Product Code: QZI
• UDI-Device Identifier: 00763000871741
• UDI-Public: 00763000871741
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/09/2025

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: 11/20/2025
• Device Model Number: AFR-00001
• Device Catalogue Number: AFR-00001
• Device Lot Number: 0229895508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White