BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSITE MULTI-ELECTRODE ARRAY CATHETER

    MDR report key: 1833608 · Received September 8, 2010

    Report

    Report Number
    2184149-2010-00027
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    MTD
    PMA / PMN Number
    K983456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE RETURNED CATHETER CONFIRMED THAT THE CATHETER PASSED ALL FUNCTIONAL REQUIREMENTS. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS CATHETER MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED EFFUSION REMAINS UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OUTFLOW TRACT ABLATION PROCEDURE, THE RIGHT VENTRICLE WAS MAPPED WITH THE ARRAY CATHETER AND THEN THE ABLATION CATHETER WAS USED TO APPLY 6 RF APPLICATIONS. THE PHYSICIAN THEN REMOVED THE ARRAY CATHETER FROM THE RIGHT VENTRICLE WITHOUT DIFFICULTY AND DECIDED TO INSERT IT RETROGRADE THROUGH THE ARTERIAL LINE INTO THE LEFT VENTRICLE. THE PTS ACT AT THE TIME WAS 300. WHILE THE ARRAY CATHETER WAS STILL IN LOW PROFILE, THE PT BECAME UNSTABLE AND AN ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND 500 CC OF FLUID WAS EXTRACTED. THE PT STABILIZED WITH NO FURTHER CONSEQUENCES. THE PHYSICIAN WAS UNCERTAIN AS TO THE CAUSE OF THE EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSITE MULTI-ELECTRODE ARRAY CATHETER ARRAY CATHETER MTD ST. JUDE MEDICAL, AF DIVISION EC1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SAFIRE BI-DIRECTIONAL ABLATION CATHETER