BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFERA

    MDR report key: 23383645 · Received October 24, 2025

    Report

    Report Number
    3012520654-2025-00166
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    July 24, 2025
    Report Date
    October 24, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    UDI-DI
    00763000973391
    PMA / PMN Number
    P240013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE AFR-00001 SPHERE 9 CATHETER WITH LOT NUMBER 0230829309 WAS RETURNED AND ANALYZED. DURING EXTERNAL VISUAL INSPECTION, THE SPHERE 9 CATHETER WAS FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. A YELLOW STICKER/TAG/TAPE WAS OBSERVED ON THE SHAFT. THE CIRRIS TESTER WAS USED ON THE CATHETER FOR THE SHORTS AND MAPPING TESTS, WHICH HAD PASSING RESULTS. A MULTIMETER AND A BREAKOUT FIXTURE (FXT-00161) WAS USED TO CHECK FOR ANY SHORTS TO BRAID, BUT NONE WERE FOUND. A MULTIMETER AND BREAKOUT FIXTURE (FXT-00161) WERE USED TO CHECK FOR SHORTS TO THE BRAID, NO SHORTS WERE IDENTIFIED. THE CATHETER WAS FUNCTIONALLY TESTED USING TEST CAPITAL EQUIPMENT. RADIOFREQUENCY (RF) AND PULSED FIELD ABLATIONS WERE COMPLETED SUCCESSFULLY WITH THE CATHETER. A NEW MAP WAS STARTED, AND THE CATHETER WAS ABLE TO MAP APPROPRIATELY. IN CONCLUSION, THE REPORTED YELLOW DISCOLORATION/SUBSTANCE ISSUE WAS CONFIRMED THROUGH TESTING AND THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO POLYAMIDE TAPE ON THE CATHETER. 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, WHEN THE FIRST SPHERE 9 CATHETER WAS OPENED, IT WAS FOUND TO HAVE AN UNKNOWN YELLOW DISCOLORATION/SUBSTANCE ON THE SHAFT. THE SPHERE 9 CATHETER WAS REPLACED. WHILE USING THE REPLACEMENT CATHETER, ARTIFACT WAS OBSERVED ON THE TEMPERATURE GRAPH DURING ABLATION WHEN USING THE REPLACEMENT CATHETER, AND THE GLOBE APPEARED VERY RED. TEMPERATURE READINGS RANGED FROM BODY TEMPERATURE TO 55°C AND SENSING/SIGNAL INACCURATE TEMPERATURE WAS NOTED. TROUBLESHOOTING STEPS INCLUDED REBOOTING THE AFFERA SYSTEM, RECONNECTING, AND REPLACING THE CATHETER EXTENSION CABLE, WITHOUT RESOLUTION. REPLACING THE SPHERE 9 CATHETER RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH AFFERA. IT WAS ALSO NOTED THAT THE LOT NUMBER ON THE PACKAGING DOES NOT ALWAYS MATCH THE LOT NUMBER ON THE CATHETERS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790104 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00001 0230829309 00763000973391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AFR-00001 CATHETER