BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFERA

    MDR report key: 22327229 · Received June 25, 2025

    Report

    Report Number
    3012520654-2025-00074
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 20, 2025
    Report Date
    December 12, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    UDI-DI
    00763000973391
    PMA / PMN Number
    P240013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: AN IMAGE AND THE AFR-00001 SPHERE CATHETER WERE RETURNED AND ANALYZED. THE IMAGE SHOWED A SPHERE TIP AND IT SEEMS THERE ARE DARK RESIDUE/CHAR ON THE SPHERE. DURING EXTERNAL VISUAL INSPECTION, THE SPHERE CATHETER WAS FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. THE CIRRIS TESTER WAS USED TO CONDUCT SHORTS AND MAPPING TESTS ON THE CATHETER, WHICH RESULTED IN A FAILURE. THE TESTS INDICATED AN OPEN CIRCUIT AT THE TIP ELECTRODE, CORRESPONDING TO ZONE 1.A MULTIMETER AND A BREAKOUT FIXTURE (FXT-00161) WAS USED TO CHECK FOR ANY SHORTS TO BRAID, BUT NONE WERE FOUND. A DETAILED INSPECTION OF THE LATTICE STRUCTURE WAS CONDUCTED, AND EVIDENCE CORRESPONDING TO THE OPEN CIRCUITS IDENTIFIED DURING THE SHORTS AND MAPPING TESTS WERE CAPTURED. IN CONCLUSION, THE REPORTED CHAR FORMATION WAS CONFIRMED THROUGH PHOTO ANALYSIS, BUT NOT THROUGH ANALYSIS OF THE PHYSICAL PRODUCT. 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

    CORRECTION H11: THE PHYSICAL PRODUCT HAS NOT BEEN RETURNED OR ANALYZED AT THIS POINT IN TIME. IF THIS PRODUCT IS RETURNED TO MEDTRONIC AT A FUTURE DATE, THIS EVENT WILL BE RE-OPENED FOR ADDITIONAL ANALYSIS AND REVIEW. CORRECTION H6: FDM/ANNEX B B01 REMOVED FROM EVENT. CORRECTION D9: REMOVED "DEVICE AVAILABLE FOR EVALUATION: YES" AND REMOVED RETURN DATE. 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 AFR-00001 SPHERE 9 CATHETER WITH LOT 0230752675 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 CONDUCT SHORTS AND MAPPING TESTS ON THE CATHETER, WHICH RESULTED IN A FAILURE. THE TESTS INDICATED AN OPEN CIRCUIT AT THE TIP ELECTRODE, CORRESPONDING TO ZONE 1.A MULTIMETER AND A BREAKOUT FIXTURE (FXT-00161) WAS USED TO CHECK FOR ANY SHORTS TO BRAID, BUT NONE WERE FOUND. A DETAILED INSPECTION OF THE LATTICE STRUCTURE WAS CONDUCTED, AND EVIDENCE CORRESPONDING TO THE OPEN CIRCUITS IDENTIFIED DURING THE SHORTS AND MAPPING TESTS WERE CAPTURED. IN CONCLUSION, THE REPORTED "CHAR FORMATION" ISSUE WAS NOT OBSERVED THROUGH TESTING OF THE PHYSICAL PRODUCT. THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE OPEN CIRCUITS. 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, CHAR FORMATION WAS OBSERVED ON THE SURFACE OF THE CATHETER. APPROXIMATELY THIRTY SIXTY-SECOND RADIOFREQUENCY LESIONS WERE DELIVERED USING VENTRICULAR TACHYCARDIA AFFERA SETTINGS. THE PHYSICIAN REMOVED THE SPHERE-9 CATHETER FROM THE BODY TO RE-MAP WITH A ANOTHER MANUFACTURER'S MAPPING CATHETER, AT WHICH POINT CHAR FORMATION WAS NOTICED ON THE LATTICE OF THE SPHERE-9 CATHETER. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT SPHERE-9 CATHETER TO DELIVER ADDITIONAL RADIOFREQUENCY LESIONS. THE CASE WAS COMPLETED WITH AFFERA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130925 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00001 0230570942 00763000973391

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male