BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY¿ COOL FLEX¿ ABLATION CATHETER IRRIGATED 4 MM TIP THERMOCOUPLE QUADRIPOLA

    MDR report key: 12983525 · Received December 13, 2021

    Report

    Report Number
    2030404-2021-00091
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 22, 2021
    Report Date
    January 20, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3 ELECTRODES 1-4 MET SPECIFICATIONS OF ACCEPTABLE RESISTANCE VALUES WITH NO OPEN OR SHORT CIRCUITS DETECTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED SIGNAL ISSUE REMAINS UNKNOWN.

    Description of Event or Problem · 0

    MANUFACTURER REPORT NUMBER: 2030404-2021-00090. DURING AN SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE, THE CATHETER WAS INSERTED INTO THE RIGHT ATRIUM, BUT A CLEAR SIGNAL WAS UNABLE TO BE ACHIEVED. THE CATHETER WAS REPLACED, BUT THE ISSUE OCCURRED WITH THE SECOND CATHETER. A THIRD CATHETER WAS USED AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. A PROCEDURE DELAY OCCURRED DUE TO THIS ISSUE.

    Description of Event or Problem · 0

    MANUFACTURER REPORT NUMBER: 2030404-2021-00090. DURING AN SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE, THE CATHETER WAS INSERTED INTO THE RIGHT ATRIUM, BUT A CLEAR SIGNAL WAS UNABLE TO BE ACHIEVED. THE CATHETER WAS REPLACED, BUT THE ISSUE OCCURRED WITH THE SECOND CATHETER. A THIRD CATHETER WAS USED AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. A PROCEDURE DELAY OCCURRED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888250 THERAPY¿ COOL FLEX¿ ABLATION CATHETER IRRIGATED 4 MM TIP THERMOCOUPLE QUADRIPOLA CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL A088015 7430594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown COOL FLEX