BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE

    MDR report key: 11163068 · Received January 13, 2021

    Report

    Report Number
    3008452825-2021-00013
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    January 4, 2021
    Report Date
    April 8, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    UDI-DI
    05414734201322
    PMA / PMN Number
    K002976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 6F, QUADRIPOLAR, JSN, SUPREME EP CATHETER WAS RECEIVED FOR EVALUATION. THE REPORTED DAMAGE WAS CONFIRMED. FURTHER INVESTIGATION FOUND THAT THE SEPARATION IN THE SHAFT WAS DUE TO INSUFFICIENT BONDING BETWEEN THE GREY AND BLACK PORTIONS OF THE BRAIDED SHAFT. ACTIONS HAVE BEEN TAKEN TO PREVENT REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    DURING THE SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE CATHETER TIP WAS BROKEN. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61315 SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL 401436 7427761 05414734201322

    Patients

    Seq Age Sex Outcome Treatment
    1