BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFERA

    MDR report key: 23823931 · Received December 16, 2025

    Report

    Report Number
    9612164-2025-06236
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    December 10, 2025
    Report Date
    March 17, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    QZI
    UDI-DI
    00763000973513
    PMA / PMN Number
    P240013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE SPHERE CATHETER WITH LOT NUMBER AA0013055880 WAS RETURNED AND ANALYZED. DURING EXTERNAL VISUAL INSPECTION, THE CATHETER WAS FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. THE CIRRIS TESTER WAS USED TO PERFORM SHORTS AND MAPPING TESTS, WHICH RESULTED IN A FAILURE. AN OPEN CIRCUIT WAS IDENTIFIED AT D4 ELECTRODE OF THE CATHETER. AN OPTICAL INSPECTION OF THE LATTICE STRUCTURE WAS CONDUCTED, NO ANOMALIES WERE OBSERVED. THE HANDLE WAS OPENED TO EXAMINE THE ELECTRODE WIRES AT D4. NO ANOMALIES WERE OBSERVED IN ZONE 5. A MULTIMETER AND BREAKOUT FIXTURE (FXT-00161) WERE USED TO CHECK FOR CONNECTION FOR D4, AN OPEN CIRCUIT WAS IDENTIFIED ON THE GREEN WIRE FOR D4 FROM THE HANDLE AREA IN ZONE 5 TO THE LATTICE REGION IN ZONE 1. THE CATHETER WAS CONNECTED TO THE FINAL FUNCTIONAL TESTER (E-052) FOR IMPEDANCE AND THERMOCOUPLE TESTS. THE IMPEDANCE PASSED WHILE THE THERMOCOUPLE TEST FAILED AT D4. IN CONCLUSION, THE REPORTED TISSUE IN TIP WAS NOT CONFIRMED THROUGH ANALYSIS. THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE OPEN CIRCUIT. 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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A TEMPERATURE SENSOR FAULT OCCURRED. THE FAULT MESSAGE PERSISTED AFTER REPLACING THE CATHETER EXTENSION CABLE. THE CATHETER WAS SUBSEQUENTLY REPLACED, AFTER WHICH THE SYSTEM FUNCTIONED CORRECTLY. UPON REMOVAL OF THE CATHETER FOR REPLACEMENT, A SMALL THROMBUS WAS OBSERVED, AND THE CTA LEVEL HAD BEEN ABOVE 350. THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205339 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC IRELAND AFR-00001 0013055880 00763000973513

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown