BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFERA

    MDR report key: 21230667 · Received January 24, 2025

    Report

    Report Number
    3012520654-2025-00008
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    January 3, 2025
    Report Date
    April 7, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    UDI-DI
    00763000871741
    PMA / PMN Number
    P240013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE AFR-00001 CATHETER WITH LOT NUMBER 0229796280 WAS RETURNED AND ANALYZED. DURING EXTERNAL VISUAL INSPECTION, THE CATHETER WAS FOUND TO BE INTACT AND A SMALL AMOUNT OF FOREIGN MATERIAL WAS SEEN ATTACHED TO THE TIP OF THE LATTICE OF THE CATHETER. IT WAS CONFIRMED THE MATERIAL WAS ON THE TIP OF THE CATHETER. THE CIRRIS SHORTS AND MAPPING TEST WAS PERFORMED ON THE CATHETER WITH PASSING RESULTS. A MULTIMETER AND BREAKOUT FIXTURE (FXT-00161) WAS USED TO CHECK FOR SHORTS TO THE METAL BRAID, BUT NONE WERE FOUND. THE OCCLUSION TEST WAS PERFORMED ON THE CATHETER USING THE ZAXIS PD LEAK TESTER AND WAS FOUND TO HAVE PASSING RESULTS. THE CATHETER TIP WAS THEN SENT OUT FOR HISTOLOGY TESTING. IN CONCLUSION, THE MATERIAL IN THE CATHETER TIP ISSUE WAS CONFIRMED THROUGH TESTING. 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 MATERIAL WAS FOUND IN THE ABLATION CATHETER POST-PROCEDURE. THE ISSUE OCCURRED DURING REMOVAL OF THE DEVICE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT, AND NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION, AND THERE WAS NO INJURY AS A RESULT OF THE EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629479 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00001 0229796280 00763000871741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male