BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE MAPPING CATHETER - 20 MM

    MDR report key: 22815849 · Received August 15, 2025

    Report

    Report Number
    9617601-2025-01001
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    May 30, 2024
    Report Date
    August 15, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/54 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE, EXPIRATION DATE, AND UDI CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ITALIAN REGISTRY IN THE SETTING OF ATRIAL FIBRILLATION ABLATION WITH RIVAROXABAN ¿ IRIS. MINERVA CARDIOLOGY AND ANGIOLOGY. 2024. 72(6):625-37 DOI: 10.23736/S2724-5683.24.06546-3. 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

    LITERATURE WAS REVIEWED REGARDING A REGISTRY IN THE SETTING OF ATRIAL FIBRILLATION (AF) WITH DIRECT ORAL ANTICOAGULANT. THE AUTHORS DESCRIBED PATIENT WHO EXPERIENCED CARDIAC TAMPONADE TREATED WITH PERICARDIOCENTESIS, MINOR BLEEDING, AND GROIN HEMATOMA. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS RELATED TO THE PRODUCTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2726871 ACHIEVE MAPPING CATHETER - 20 MM CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC MEXICO S. DE R.L. DE CV 990063-020

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention UNKNOWN MANUFACTURER'S BALLOON CATHETER.