BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE J

    MDR report key: 11311577 · Received February 10, 2021

    Report

    Report Number
    3008452825-2021-00090
    Event Type
    Injury
    Date Received
    February 10, 2021
    Date of Event
    February 4, 2021
    Report Date
    August 30, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    UDI-DI
    05415067011510
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE QUADRIPOLAR, UNI-DIRECTIONAL, CURVE J, FLEXIBILITY ABLATION CATHETER WAS RECEIVED FOR EVALUATION. MICROSCOPIC INSPECTION REVEALED BLS IN THE EXTENSION TUBE AND THROUGHOUT THE LENGTH OF THE FLUID LUMEN. AN OCCLUSION WAS NOTED 40.0¿ DISTAL TO THE EXTENSION TUBE OPENING. THE FLOW RATE COULD NOT BE MEASURED AND THE CATHETER COULD NOT BE PRIMED DUE TO THE BLOOD-LIKE SUBSTANCE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE IRRIGATION OCCLUSION IS CONSISTENT WITH DAMAGE DURING USE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, THE INVESTIGATION CODING WAS UPDATED TO INVESTIGATION FINDINGS MECHANICAL PROBLEM IDENTIFIED C07 : BLOCKAGE IDENTIFIED C0708 AND INTERNAL CLARIFYING CODE EP - FLOW OBSTRUCTION, FM/BLS OCCLUDING IRRIGATION C070800-002.

    Description of Event or Problem · 1

    DURING A PROCEDURE, AN OBSTRUCTION WAS NOTED DUE TO A CLOT. UPON CLOSER INSPECTION, IT WAS DETERMINED THAT THE IRRIGATION VALVE WAS CLOSED AND LIQUID COULD NOT IRRIGATE PROPERLY. THIS HAPPENED AT THE START OF THE PROCEDURE, WITHOUT ANY RADIOFREQUENCY ABLATION APPLICATION PERFORMED. THE CATHETER WAS REMOVED AND A NEW ONE WAS USED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206584 FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE J CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL A701159 7441525 05415067011510

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other