BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPREME EP CATHETER, 6F, QUADRIPOLAR, CRD

    MDR report key: 2536136 · Received April 10, 2012

    Report

    Report Number
    3005188751-2012-00110
    Event Type
    Injury
    Date Received
    April 10, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRF
    PMA / PMN Number
    K894500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. 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

    SAME CASE AS MFG REPORT: 3005188751-2012-00111 AND 3005188751-2012-00112. IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE TO TREAT PREMATURE VENTRICULAR CONTRACTIONS (PVC), A CARDIAC PERFORATION WAS NOTED. THE LIVEWIRE EP CATHETER WAS POSITIONED IN THE CORONARY SINUS. ONE SUPREME EP CATHETER WAS PLACED IN THE HIS POSITION. ONE SUPREME EP CATHETER WAS PLACED IN THE RIGHT VENTRICLE NEAR THE APEX. THE BIOSENSE WEBSTER ABLATION CATHETER WAS PLACED IN THE LEFT VENTRICLE VIA RETROGRADE AORTIC APPROACH. THE PVC'S WERE MAPPED USING THE ENSITE MAPPING SYSTEM COMBINED WITH A PACE-MAPPING TECHNIQUE ON A BARD RECORDING SYSTEM. EARLY ACTIVATION OF THE CLINICAL PVC WAS FOUND AND ABLATED. PVC'S WERE GREATLY REDUCED. THE PATIENT WAS PLACED ON ISOPROTERENOL AND AFTER WASHOUT, EPINEPHRINE. THE CLINICAL PVC SEEMED TO BE GONE. THE CASE WAS DEEMED SUCCESSFUL AND ENDED. WHEN THE PATIENT WAS BEING TAKEN OUT OF THE ROOM, HER BLOOD PRESSURE DROPPED NOTICEABLY. SHE WAS RUSHED INTO ANOTHER LAB WHERE A PERICARDIOCENTESIS WAS PERFORMED WHICH YIELDED 600ML OF BLOOD FROM THE PERICARDIAL SPACE. THE PATIENT IS NOTED TO BE "FINE" AND WAS SCHEDULED TO BE DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPREME EP CATHETER, 6F, QUADRIPOLAR, CRD SUPREME EP, 6F, CRD DRF ST. JUDE MEDICAL, AF DIVISION 401442 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention BARD RECORDING SYSTEM| A LIVEWIRE EP CATHETER| A BIOSENSE WEBSTER ABLATION CATHETER| ENSITE MAPPING SYSTEM| A SUPREME EP CATHETER