BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2201953 · Received August 5, 2011

    Report

    Report Number
    3005188751-2011-00134
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRF
    PMA / PMN Number
    K002976
    Adverse Event
    Yes
    Product Problem
    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 CRT IMPLANT PROCEDURE, A PERFORATION OF THE CORONARY SINUS OCCURRED. THE PHYSICIAN CANULATED THE CORONARY SINUS (CS) WITH A CPS DIRECT DEVICE AND A SUPREME EP CATHETER TO VISUALIZE THE CORONARY SINUS. WHEN HE THOUGHT, HE WAS INSIDE THE CORONARY SINUS, THE PHYSICIAN INJECTED CONTRAST THROUGH THE VALVE OF THE CPS DIRECT DEVICE AND NOTED THE PERFORATION. THE PT REMAINED STABLE WITHOUT FURTHER INTERVENTION SO THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT INSERTION OF THE CS LEAD. AN EPICARDIAL LEAD WILL BE PLACED IN THE FUTURE. NO FURTHER PT COMPLICATIONS WERE REPORTED. THE PT STATUS IS LISTED AS FINE.

    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 3342349

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CPS DIRECT DEVICE| (DS2C002/115 S/N: (B)(4))