BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFERA

    MDR report key: 21114235 · Received January 9, 2025

    Report

    Report Number
    3012520654-2025-00004
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    January 6, 2025
    Report Date
    March 4, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    PMA / PMN Number
    P240013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE VIDEO/DATA FILES AND THE AFR-00001 CATHETER WITH LOT NUMBER 0229772155 WERE RETURNED AND ANALYZED. THE LOG FILES AND VIDEO FILES WERE ANALYZED. ANALYSIS OF THE LOG FILES AS WELL AS THE RETURNED VIDEO FILES DID NOT SHOW ANY EVIDENCE OF A STEAM POP. DURING EXTERNAL VISUAL INSPECTION, THE CATHETER WAS FOUND TO BE INTACT AND NO DEFECTS WERE OBSERVED. THE CATHETER WAS FUNCTIONALLY TESTED USING THE CATHETER EXTENSION CABLE THAT WAS RETURNED ON THE TEST CAPITAL EQUIPMENT. TESTING FOUND THAT IMPEDANCE VALUES WERE OF NORMAL RANGE DURING THE PULSED FIELD (PF) AND RADIOFREQUENCY (RF) ABLATIONS. RF AND PF ABLATIONS WERE COMPLETED SUCCESSFULLY WITH THE CATHETER. A NEW MAP WAS STARTED AND THE CATHETER WAS ABLE TO MAP APPROPRIATELY. 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. IN CONCLUSION, THE REPORTED "STEAM POP" ISSUE WAS NOT ABLE TO BE CONFIRMED THROUGH DATA ANALYSIS AND TESTING. 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

    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 (RF) ABLATION PROCEDURE, A STEAM POP OCCURRED. THE PROCEDURE CONTINUED AND THE CATHETER WAS NOT REPLACED. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364353 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00001 0229772155

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female