BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHILLI II®

    MDR report key: 3242260 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04901
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    LPB
    PMA / PMN Number
    P980003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST ELECTROPHYSIOLOGY ABLATION PROCEDURE, A CEREBROVASCULAR ACCIDENT OCCURRED. THE PHYSICIAN PERFORMED ELECTROPHYSIOLOGY THERAPY IN THE LEFT ATRIUM USING A CHILLI II ABLATION CATHETER WITHOUT ANY ISSUES AND NO CLOT WAS OBSERVER ON ECHO. HOWEVER, SIGNS OF A RIGHT HEMISPHERE STROKE WERE OBSERVED POST PROCEDURE WHEN THE PATIENT WOKE UP IN RECOVERY. ONE WEEK POST PROCEDURE PATIENT IS PROGRESSING, BUT IS STILL EXPERIENCING LEFT SIDE WEAKNESS AND APHASIA AND IS IN OUT-PATIENT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342981 CHILLI II® CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BOSTON SCIENTIFIC - SAN JOSE M0049031K20

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other