BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, EL

    MDR report key: 22216556 · Received June 16, 2025

    Report

    Report Number
    3008452825-2025-00282
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    May 23, 2025
    Report Date
    August 22, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRF
    UDI-DI
    05414734200523
    PMA / PMN Number
    K151622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. ONE 5F, QUADRIPOLAR, JSN, RESPONSE EP CATHETER WAS RECEIVED FOR EVALUATION. THE SHAFT OF THE CATHETER SHAFT WAS NOTED TO BE FRACTURE AT THE GRAY/BLACK SHAFT BOND JOINT. ADDITIONALLY, A FOREIGN MATERIAL WAS FOUND EMBEDDED IN THE CATHETER SHAFT MATERIAL AT THE FRACTURED BOND JOINT. THE REPORTED ISSUE WILL CONTINUE TO BE TRENDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, G3, H2, H3, H4, H11

    Description of Event or Problem · 0

    DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE, THE DIAGNOSTIC CATHETER FRACTURED WHILE IN THE RIGHT ATRIUM. IT WAS NOT MANEUVERING PROPERLY AND SO THE CATHETER WAS REMOVED. THE CATHETER WAS BENT AND SEPARATED AT THE BOUNDARY BETWEEN THE BLACK AND GREY PORTION OF THE CATHETER WHERE THE SHAFT AND DISTAL ELECTRODE TRANSITION. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593535 RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, EL CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ABBOTT MEDICAL 401223 10622863 05414734200523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown