BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHILLI ABLATION CATHETER

    MDR report key: 516723 · Received March 19, 2004

    Report

    Report Number
    2939222-2004-00010
    Event Type
    Injury
    Date Received
    March 19, 2004
    Date of Event
    February 16, 2004
    Report Date
    February 17, 2004
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS FOR THE FIRST OF TWO EVENTS THAT OCCURRED DURING A SINGLE PROCEDURE (SEE MDR 2939222-2004-00011 FOR THE SECOND EVENT. THE ACTUAL SEQUENCE OF EVENTS IS UNK). DURING THE MAPPING AND ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA (VT), THE SHAFT OF THE CHILLI CATHETER ALLEGEDLY DAMGED THE LEFT BUNDLE BRANCH OF THE BUNDLE OF HIS. AFTER VT TERMINATION WITH RADIOFREQUENCY (RF) ENERGY, A WIDE AND BIZARRE CONDUCTED QRS COMPLEX WAS NOTED ON A 12-LEAD ECG THAT WAS DIAGNOSED AS A LEFT BUNDLE BRANCH BLOCK (LBBB) WITH A RIGHT AXIS DEVIATION. AFTER RF TERMINATION OF VT, SINUS RHYTHM WAS CONDUCTED WITH A WIDE LBBB, WITH A RIGHTWARDS AXIS AS DETERMINED IN THE EP STUDY, WITH AN HV OF 144MS THAT GRADUALLY DECREASED TO 88MS BY END PROCEDURE, THOUGH THE BBB REMAINED. THE PT HAD A PRE-EXISTING ICD, THEREFORE NO FURTHER ACTION WAS REQUIRED. THE PT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILLI ABLATION CATHETER COOLED RF ABLATION CATHETER LPB EP TECHNOLOGIES, INC. 3006 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention