BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFERA

    MDR report key: 22575373 · Received July 23, 2025

    Report

    Report Number
    3012520654-2025-00096
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 16, 2025
    Report Date
    October 20, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE AFR-00001 CATHETER WITH LOT NUMBER 0230829263 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 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. 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. THE CATHETER WAS FUNCTIONALLY TESTED USING TEST CAPITAL EQUIPMENT. RADIOFREQUENCY (RF) AND PULSE FILED (PF) ABLATIONS WERE COMPLETED SUCCESSFULLY WITH THE CATHETER. A NEW MAP WAS STARTED, AND THE CATHETER WAS ABLE TO MAP APPROPRIATELY. NO STEAM POPS WERE HEARD OR VISUALLY DETECTED. IN CONCLUSION, THE REPORTED ISSUE (STEAM POP) WAS NOT CONFIRMED THROUGH ANALYSIS AND THE CATHETER PASSED THE RETURNED PRODUCT INSPECTION 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

    PRODUCT EVENT SUMMARY: THE DATA FILES WERE RETURNED AND ANALYZED. ONE IMAGE FILE WAS RETURNED FROM THE FIELD AND WAS AN IMAGE OF THE ABLATION SCREEN WITH THE ACTIVATION MAP OF THE HEART. OBSERVATION OF THE GRAPH AT LESION THREE FOR RADIOFREQUENCY (RF) ABLATION, IT IS PLAUSIBLE THAT THE USER ENCOUNTERED A STEAM POP OR AN IMPENDING STEAM POP. LOG FILES WERE ANALYZED AND THE REPORTED STEAM POP ISSUE WAS PLAUSIBLE THROUGH DATA ANALYSIS. IN CONCLUSION, THE REPORTED STEM POP ISSUE WAS PLAUSIBLE THROUGH IMAGE AND LOG FILE ANALYSIS. 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 RADIOFREQUENCY ABLATION PROCEDURE, A LESION FORMATION ISSUE AND A STEAM POP OCCURRED ON THE CAVOTRICUSPID ISTHMUS (CTI) DURING THE THIRD LESION WITH THE RADIOFREQUENCY ANTERIOR PRESET. IT WAS NOTED THAT THE LESION WAS NOT STACKED ON ANOTHER LESION. THE PATIENT'S VITALS AND IMAGING WAS ASSESSED AND THERE WAS NO EFFUSION OR CHANGE IN VITALS OBSERVED. 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
    1869958 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00001 0230829263 00763000973391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female