BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL PATH¿ IRRIGATED ABLATION CATHETER

    MDR report key: 5665586 · Received May 18, 2016

    Report

    Report Number
    2030404-2016-00019
    Event Type
    Injury
    Date Received
    May 18, 2016
    Report Date
    April 26, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENTS COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    THE (B)(6) HEART VESSELS DURING (2016) JOURNAL PUBLISHED AN ARTICLE ON 05 DECEMBER 2014 INDICATING THREE PATIENTS DEVELOPED CARDIAC TAMPONADE DURING THE PROCEDURE, WHICH WAS TREATED WITH A PERICARDIOCENTESIS. FURTHER INFORMATION REGARDING THESE EVENTS IS NOT AVAILABLE. (HEART VESSELS (2016) 31:397-401).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319079 COOL PATH¿ IRRIGATED ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention