BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEXION SPIRAL BI-DIRECTIONAL CATHETER, 7F

    MDR report key: 2201865 · Received August 5, 2011

    Report

    Report Number
    3005188751-2011-00138
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRF
    PMA / PMN Number
    K072012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE MAPPING THE LEFT ATRIUM WITH THE REFLEXION SPIRAL CATHETER, REMOVAL DIFFICULTIES OCCURRED. THE PHYSICIAN INSERTED THE REFLEXION SPIRAL CATHETER INTO THE LEFT VENTRICLE VIA TRANSSEPTAL ACCESS. HE THEN BEGAN TO CREATE GEOMETRY USING NAVX. WHEN THE PHYSICIAN ATTEMPTED TO PLACE THE CATHETER AROUND THE RIPV HE FLEXED THE CATHETER 180 DEGREES AND WAS UNABLE TO MOVE THE CATHETER OUT OF THE 180 DEGREE FLEXION. THE PHYSICIAN SPENT SEVERAL MINS MANIPULATING THE CATHETER IN AN ATTEMPT TO PULL IT BACK INTO THE SL1 SHEATH. THE CATHETER WOULD NOT STRAIGHTEN. ON FLUOROSCOPY, THE LOOP PORTION OF THE CATHETER APPEARED TO BE CAUGHT ON ITSELF AND THE SHEATH. THE PHYSICIAN PULLED THE CATHETER AND SHEATH ACROSS THE SEPTUM INTO THE RIGHT ATRIUM. AT THIS POINT, THE CATHETER RELEASED AND WAS ABLE TO BE PULLED SAFELY INTO THE SL1 SHEATH. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH AN SJM 90/180 REFLEXION SPIRAL CATHETER. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEXION SPIRAL BI-DIRECTIONAL CATHETER, 7F REFLEXION SPIRAL, 7F DRF ST. JUDE MEDICAL, AF DIVISION D402893 3302309

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR