BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFERA

    MDR report key: 22869959 · Received August 22, 2025

    Report

    Report Number
    3012520654-2025-00117
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 22, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    UDI-DI
    00763000973391
    PMA / PMN Number
    P240013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: AN IMAGE WAS RETURNED AND ANALYZED. THE RETURNED IMAGE SHOWED SMALL RED DEBRIS INSIDE A CUP FILLED WITH WATER. IN CONCLUSION, THE REPORTED ISSUE (FOREIGN MATERIAL) WAS CONFIRMED THROUGH 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

    PRODUCT EVENT SUMMARY: THE AFR-00001 SPHERE CATHETER WITH LOT NUMBER 0230901940 WAS RETURNED AND ANALYZED. DURING EXTERNAL VISUAL INSPECTION, THE SPHERE CATHETER WAS FOUND TO BE INTACT, AND NO DEFECTS WERE OBSERVED. NO FOREIGN MATERIAL WAS OBSERVED ON THE NITINOL SPHERE. 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 UNDERWENT FUNCTIONAL TESTING USING TEST CAPITAL EQUIPMENT. BOTH RF AND PF ABLATIONS WERE SUCCESSFULLY PERFORMED WITH THE CATHETER. A NEW MAPPING PROCEDURE WAS INITIATED, AND THE CATHETER DEMONSTRATED EFFECTIVE MAPPING CAPABILITIES. THE CATHETER WAS FLUSHED THROUGH THE LUMEN WITHOUT ENCOUNTERING ANY RESISTANCE. ADDITIONALLY, A THOROUGH VISUAL INSPECTION OF THE LATTICE CONFIRMED THE ABSENCE OF FOREIGN MATERIAL INSIDE THE NITINOL SPHERE, AND THE NOZZLE REMAINED INTACT. IN CONCLUSION THE REPORTED MATERIAL IN THE TIP 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 LATER REPORTED THAT THE MATERIAL FOUND WITHIN THE LATTICE OF THE CATHETER WAS SMALL, LOOSE, AND DARK RED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, DEBRIS AND FOREIGN MATERIAL WERE FOUND IN THE CATHETER AROUND THE TIP DURING USE. THE DEBRIS WAS DISCOVERED WHEN THE CATHETER WAS REMOVED FROM THE BODY FOR RE-ADJUSTMENT. AN ATTEMPT WAS MADE TO FLUSH THE CATHETER, AND MOST OF THE MATERIAL WAS REMOVED. THE CATHETER WAS THEN REPLACED, AND 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
    1557951 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00001 0230901940 00763000973391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown