BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY FIXED CATH 6F ELECTROPHYSIOLOGY CATHETER

    MDR report key: 1820029 · Received August 24, 2010

    Report

    Report Number
    2030404-2010-00103
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    DRF
    PMA / PMN Number
    K946333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN EVALUATION HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ABLATION PROCEDURE, WHEN THE CATHETER WAS INSERTED INTO THE CORONARY SINUS, BLOOD LEAKED FROM THE CONNECTION BETWEEN THE HANDLE AND THE SHAFT. THERE WERE NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY FIXED CATH 6F ELECTROPHYSIOLOGY CATHETER INQUIRY FIXED ELECTROPHYSIOLOGY CATHETER DRF ST. JUDE MEDICAL, IRVINE 86010 K26902

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK