BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFERA

    MDR report key: 24474645 · Received February 27, 2026

    Report

    Report Number
    9612164-2026-01055
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 30, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    QZI
    UDI-DI
    00763000973506
    PMA / PMN Number
    P240013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: DATA FILES AND THE AFR-00001 SPHERE CATHETER WITH LOT NUMBER 0012978778 WAS RETURNED AND ANALYZED. THE FILES SHOWED THAT MULTIPLE MESSAGES WERE RECEIVED DURING THE PROCEDURE. (B)(6) 2026, 07:21:39 RFG CRITICAL PUMP STOPPED' (B)(6) 2026, 07:21:40 WARNING LOCATION REFERENCE NOT CALIBRATED' (B)(6) 2026, 07:21:40 RFG CRITICAL GENERATOR UI NOT RESPONDING' (B)(6) 2026, 07:21:43 CRITICAL NO LOCATION PATCHES DETECTED' (B)(6) 2026, 07:47:33 RFG CRITICAL PUMP HARDWARE FAULT' DURING EXTERNAL VISUAL INSPECTION, THE SPHERE 9 CATHETER WAS FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. THE CIRRIS TESTER WAS USED ON THE CATHETER FOR SHORTS AND MAPPING TESTS, AND THE TESTS PASSED SUCCESSFULLY. 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 CLINICAL ISSUE, HYPOTENSION AND EFFUSION, WAS NOT CONFIRMED THROUGH ANALYSIS. THE SPHERE 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.

    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 CARDIAC ABLATION PROCEDURE, THE PATIENT EXPERIENCED BLOOD POOLING IN THE PERICARDIUM AND A DROP IN BLOOD PRESSURE, WHICH WAS FIRST NOTED SHORTLY AFTER INITIAL ACCESS. MOST OF THE BLOOD POOLING WAS OBSERVED AROUND THE LATERAL RIGHT VENTRICULAR LEAD. THE EFFUSION WAS IDENTIFIED AFTER COMPLETION OF THE LEFT PULMONARY VEIN ISOLATION. THE RIGHT PULMONARY VEIN ISOLATION WAS COMPLETED AND THEN A WATCHMAN PROCEDURE WAS ADMINISTERED BEFORE DRAINING THE PERICARDIUM. THERE WAS MINOR ANESTHESIA SUPPORT, SYMPATHOMIMETIC MEDICATION WAS ADMINISTRATED AND CORONARY SINUS PACING WERE USED TO MANAGE THE SITUATION. THE PROCEDURE WAS TEMPORARILY INTERRUPTED, AND PERICARDIOCENTESIS WAS PERFORMED TO RESOLVE THE EFFUSION. THE CASE WAS COMPLETED. THE PATIENT SUSTAINED A TEMPORARY INJURY AND WAS KEPT OVERNIGHT FOR MONITORING, EXTENDING THE PLANNED HOSPITALIZATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541535 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC IRELAND AFR-00001 0012978778 00763000973506

    Patients

    Seq Age Sex Outcome Treatment
    1