BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSIUS¿ RMT ELECTROPHYSIOLOGY

    MDR report key: 2013434 · Received March 10, 2011

    Report

    Report Number
    2029046-2011-00018
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    P950005/S18
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR EVALUATION. BWI CONCOMITANT PRODUCT: STOCKERT SYSTEM US CAT NUM S7001, (B)(4). OTHER CONCOMITANT PRODUCT: NAVX 3D MAPPING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VT IDIOPATHIC PROCEDURE, THE CATHETER BECAME ENTRAPPED/WRAPPED IN THE CHORDAE TENDON. THE EVENT WAS NOTICED WHEN THE PHYSICIAN WAS TRYING TO RETRACT THE CATHETER. THE PHYSICIAN PULLED OUT THE CATHETER ABRUPTLY FROM THE PATIENT TO REMOVE THE CATHETER. THE PROCEDURE WAS CANCELLED DUE TO SEVERE TRICUSPID REGURGITATION WHEN TRANSTHORACIC ECHO WAS PERFORMED. IT WAS UNCLEAR WHETHER THE REGURGITATION WAS DUE TO CHORDAE TEAR OR SOME OTHER DAMAGE TO THE TRICUSPID APPARATUS. THE PHYSICIAN CUT UP THE CATHETER AFTER REMOVING FROM THE PATIENT "TO SEE HOW IT EASY IT WOULD BE TO CUT" AND IT WAS SUBSEQUENTLY DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION AND WAS RELEASED THE FOLLOWING DAY. PATIENT HAD AN OPEN HEART SURGERY ON (B)(6) 2011. PATIENT'S PROGNOSIS IS SATISFACTORY. PATIENT IS STILL IN THE HOSPITAL AS OF (B)(6) 2011. BWI FIELD SERVICE ENGINEER CONTACTED THE CUSTOMER FOR SERVICE AND TESTING APPOINTMENT REGARDING THE STOCKERT SYSTEM. CUSTOMER DECLINED SERVICE AND STATED THAT BWI PRODUCTS WERE NOT AT FAULT FOR THE PATIENT'S INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELSIUS¿ RMT ELECTROPHYSIOLOGY CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1249-02-S 15121359

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| L| R