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

Model Number	AFR-00001
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
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 foreign material was found to be in the catheter tip upon removal of the catheter after a cardiac ablation procedure.The patient was in sinus rhythm upon arrival to the procedure.The patient successfully had a pulmonary vein isolation (pvi), wide area circumferential ablation (waca), cavotricuspid isthmus (cti), mitral, roof line, inferior line, posterior wall ablations done, as well as a touch up to a cti line done a few months prior.It was noted that there was no material in the catheter tip whenthe catheter was removed from the right atrium for transeptal procedure, so the catheter was prepped a second time prior to insertion back into the patient and advanced into the left atrium for mapping, followed by the right atrium for mapping.No ablations were done while the catheter was in the body for the second time.It is unknown where the material originated from, but it was reported that the catheter had been in the left atrium, right atrium, inferior vena cava, and femoral vein.The physician thought he removed the catheter while exposed outside of the sheath, as he did not remember withdrawing the catheter into the sheath, and then removing the sheath.It was noted that a clear, pinkish, jelly-like substance was adhered to the lattice tip, covering about 1/8th of the lattice tip.There was no impact to the procedure, as this was noticed upon catheter removal at the end of the procedure.The outcome of this case is unknown.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 IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 25350321
• Report Number: 9612164-2026-02824
• Device Sequence Number: 10736962
• Product Code: QZI
• UDI-Device Identifier: 00763000973506
• UDI-Public: (01)00763000973506(17)270320(10)0013299086(20)01
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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 Model Number: AFR-00001
• Device Catalogue Number: AFR-00001
• Device Lot Number: 0013299086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 02/18/2026
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 159 LB