BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFERA

    MDR report key: 23267844 · Received October 10, 2025

    Report

    Report Number
    2182207-2025-02751
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 17, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    UDI-DI
    00763000973391
    PMA / PMN Number
    P240013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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: THE LOG FILES AND THE AFR-00001 LOOP CATHETER 0231480963 PRODUCT ANALYSIS #(B)(4): BIN FILE ANALYSIS DATE: (B)(6) 2025 EVENT DATE:15-SEP-2025 ANALYSIS CONDUCTED: LOG FILES WERE ANALYZED. RESULT OF ANALYSIS: LOG FILES RETURNED FROM THE FIELD SHOWED THE FOLLOWING TIME STAMPS/ERRORS: POSSIBLE CATHETER SERIAL NUMBERS: (B)(6) FULL LOG: LOGS/73E9F70F-4826-47E3-9905-CA7FB16DB10C.TXT NOTIFICATIONS DATE DEVICE TYPE MESSAGE (B)(6) 2025 10:01:42 WARNING LOCATION REFERENCE NOT CALIBRATED' 2025-09-15 10:01:45 CRITICAL NO LOCATION PATCHES DETECTED' (B)(6) 2025 10:01:57 RFG INFORMATION REMOTE HIGH CPU USAGE' (B)(6) 2025 10:02:00 RFG INFORMATION ABL REMOTE CONTROL CONNECTING' (B)(6) 2025 10:02:04 RFG CRITICAL REMOTE CONTROL IS IN USE BUT OFFLINE!' (B)(6) 2025 10:11:08 RFG CRITICAL PUMP STOPPED' (B)(6) 2025 10:11:09 RFG CRITICAL GENERATOR UI NOT RESPONDING' (B)(6) 2025 10:33:59 CIU INFORMATION ABL CATHETER LOADING' (B)(6) 2025 10:35:54 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2025 10:35:56 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2025 10:36:49 RFG WARNING TEMPERATURE ACQUISITION CIRCUIT FAILURE' (B)(6) 2025 10:36:49 RFG INFORMATION TEMPERATURE ACQUISITION CIRCUIT DEGRADATION' (B)(6) 2025 10:36:52 RFG CRITICAL CATHETER PREP. SEQUENCE RUNNING' (B)(6) 2025 10:37:01 RFG CRITICAL PUMP STOPPED' (B)(6) 2025 10:37:13 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2025 10:37:21 RFG CRITICAL CATHETER PREP. SEQUENCE RUNNING' (B)(6) 2025 10:37:50 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2025 11:41:06 RFG WARNING ABL CATHETER NOT CONNECTED' (B)(6) 2025 11:41:06 CIU WARNING ABL CATHETER NOT CONNECTED TO HEXAMAP\XE2\X84\XA2' (B)(6) 2025 11:41:06 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' (B)(6) 2025 11:47:25 RFG CRITICAL PUMP STOPPED' (B)(6) 2025 11:47:26 RFG CRITICAL PUMP HOUSING OPEN' (B)(6) 2025 11:47:40 RFG CRITICAL RETURN 4 CONTACT QUALITY POOR' (B)(6) 2025 11:47:40 RFG WARNING RETURN 4 CQM IMPEDANCE 40% INCREASE' (B)(6) 2025 11:47:42 RFG WARNING RETURN 3 CQM IMPEDANCE 40% INCREASE' (B)(6) 2025 11:47:43 RFG WARNING RETURN 2 CQM IMPEDANCE 40% INCREASE' (B)(6) 2025 11:47:44 RFG WARNING RETURN 1 CQM IMPEDANCE 40% INCREASE' (B)(6) 2025 11:48:56 CRITICAL NO LOCATION PATCHES DETECTED' (B)(6) 2025 11:49:16 INFORMATION CIU IS OFFLINE' (B)(6) 2025 11:49:16 INFORMATION GENERATOR IS OFFLINE' (B)(6) 2025 12:04:59 CRITICAL DATA SAVE FAULT' (B)(6) 2025 12:05:32 WARNING VIDEO NOT SAVED' CONCLUSION: THE REPORTED "VENTRICULAR FIBRILATION" ISSUE WAS NOT CONFIRMED THROUGH DATA ANALYSIS. THIS REPORT WILL BE RECORDED AND TRENDED. PRODUCT ANALYSIS #(B)(4): THE SPHERE 9 CATHETER AFR-00001 LOT NO:0231480963 SN:46 WAS TESTED AS PER PRODUCT ANALYSIS GUIDELINES (B)(4). ANALYSIS DATE: (B)(6) 2025 RESULT OF ANALYSIS: THE RETURNED DEVICE IDENTIFICATION WAS LISTED WITH LOT NUMBER 0231480963. THE PRODUCT WAS RECEIVED IN A BIOHAZARD KIT. PRIOR TO PRO DUCT ANALYSIS, THE PRODUCT WAS DECONTAMINATED AS PER PROCEDURE (B)(4). DURING EXTERNAL VISUAL INSPECTION, THE SPHERE 9 CATHETER WAS FOUND TO BE INTACT, HAVE NO DEFECTS, AND NO NONCONFORMITIES. THE CIRRIS TESTER E-114 SN04 WAS USED TO PERFORM THE SHORTS AND MAPPING TESTS AND BOTH SHOWED PASSING RESULTS CATHETER WAS TESTED FOR SHORTS TO BRAID USING MULTIMETER E-270 SN01 AND NONE WERE FOUND. THE TEST CAPITAL SYSTEM WAS USED TO PERFORM A SIMULATION TEST WHICH CONCLUDED THAT PF, RF, AND MAPPING WERE NORMAL. THE DEVICE WILL BE RETAINED FOR A PERIOD OF 1 YEAR AND AVAILABLE FOR FURTHER REVIEW. THIS ANALYSIS FINDING CODE IS BEING MONITORED AS PART OF THE AFFERA DATA MONITORING PLAN. 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 LOG FILES AND AFR-00001 SPHERE CATHETER WITH LOT NUMBER 0231480963 WERE RETURNED AND ANALYZED. LOG FILES RETURNED FROM THE FIELD SHOWED MULTIPLE SYSTEM ERRORS. DURING EXTERNAL VISUAL INSPECTION, THE SPHERE 9 CATHETER WAS FOUND TO BE INTACT, HAVE NO DEFECTS, AND NO NONCONFORMITIES. THE CIRRIS TESTER E-114 SN04 WAS USED TO PERFORM THE SHORTS AND MAPPING TESTS AND BOTH SHOWED PASSING RESULTS. CATHETER WAS TESTED FOR SHORTS TO BRAID USING MULTIMETER E-270 SN01 AND NONE WERE FOUND. THE TEST CAPITAL SYSTEM WAS USED TO PERFORM A SIMULATION TEST WHICH CONCLUDED THAT PF,RF, AND MAPPING WERE NORMAL. THE REPORTED "VENTRICULAR FIBRILLATION" ISSUE WAS NOT CONFIRMED THROUGH ANALYSIS. THE CATHETER DID NOT FAIL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE SPHERE 9 CATHETER FOR RADIOFREQUENCY ABLATION NEAR A REPAIRED MITRAL VALVE, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION. THE PATIENT WAS CARDIOVERTED BACK TO NORMAL SINUS RHYTHM. THE CASE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278852 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00001 0231480963 00763000973391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L