BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPREME EP CATHETER 5F, DECAPOLAR, CSL, 120 CM

    MDR report key: 2201951 · Received August 5, 2011

    Report

    Report Number
    3005188751-2011-00135
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRF
    PMA / PMN Number
    K002976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A BIVENTRICULAR ICD IMPLANT PROCEDURE, A PERFORATION OF THE CORONARY SINUS (SC) OCCURRED. THE SURGEON USED A SUPREME EP CATHETER TO CANNULATE THE CS. ONCE THE CATHETER WAS IN THE CS, IT WAS ADVANCED AND CAUSED A PERFORATION. THE PATIENT'S CHEST WAS OPENED AND A DRAINAGE TUBE WAS INSERTED. THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS WERE IMPLANTED SO THE SURGEON DECIDED TO COMPLETE THE PROCEDURE AT THAT TIME. THE PT HAS BEEN SCHEDULED FOR A FUTURE EPICARDIAL LEAD IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPREME EP CATHETER 5F, DECAPOLAR, CSL, 120 CM SUPREME EP 5F, DECA DRF ST. JUDE MEDICAL, AF DIVISION 401863 3154585

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention