BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿

    MDR report key: 23134120 · Received September 24, 2025

    Report

    Report Number
    3008452825-2025-00473
    Event Type
    Injury
    Date Received
    September 24, 2025
    Report Date
    September 24, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN HEART RHYTHM 2025; 22:2300¿2313, HEART RHYTHM SOCIETY. "EVALUATION OF NONINVASIVE ISOCHRONAL LATE ACTIVATION MAPPING IN SCAR-RELATED VENTRICULAR TACHYCARDIA WITH ELECTROCARDIOGRAPHIC IMAGING AGAINST CONTACT MAPPING"; JOHANNA B. TONKO, MD FORTY-SEVEN PATIENTS WERE STUDIED; EPICARDIAL DATA WAS ACQUIRED IN 30. NO SIGNIFICANT DIFFERENCE IN THE ABSOLUTE LATE ACTIVATING AREAS WAS IDENTIFIED ON ECGI VS EAM; LATEST ELECTROGRAM WAS SIGNIFICANTLY LATER ON EAM. ECGI YIELDED A SENSITIVITY OF 68% AND SPECIFICITY OF 95% TO DETECT LATE ACTIVATION USING EAM AS GOLD STANDARD. EAM IDENTIFIED DZS IN 91.5% AND ECGI IN 93.6% OF PATIENTS. ECGI DETECTED SIGNIFICANTLY MORE DZS PER MAP THAN EAM BUT WITH LESS STEEP ACTIVATION GRADIENTS. SENSITIVITY FOR ECGI DZ MAPPING WAS 46.8% AND SPECIFICITY WAS 90.6% IN THE CONTEXT OF A HIGH NUMBER OF TOTAL SEGMENTS AND PREEMPTIVE EXCLUSION OF INTERPOLATED AND ARTIFICIAL DZS. AN EVENT OF A RAPID PULSELESS VENTRICULAR TACHYCARDIA INDUCTION REQUIRING CARDIOVERSION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598650 ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ Computer, diagnostic, programmable DQK ABBOTT MEDICAL

    Patients

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