BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHILLI II ABLATION CATHETER

    MDR report key: 2230993 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03728
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    LPB
    PMA / PMN Number
    P980003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 CAN NOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIAC RADIOFREQUENCY (RF) ABLATION TREATMENT PROCEDURE, TAMPONADE OCCURRED AFTER ONE ABLATION AT 30 DEGREES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILLI II ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BOSTON SCIENTIFIC - SAN JOSE UNK78

    Patients

    Seq Age Sex Outcome Treatment
    1 Other