BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO? 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 4200713 · Received October 24, 2014

    Report

    Report Number
    2029046-2014-00396
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K031161
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT BWI PRODUCTS: PRODUCT: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER US CATALOG # D132705 LOT # UNKNOWN MANUFACTURER'S REFERENCE # (B)(4) AND (B)(4), ARE RELATED TO THE SAME EVENT MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A LASSO¿ 2515 VARIABLE CIRCULAR MAPPING CATHETER AND CARTO® 3 SYSTEM AND THE CATHETER GOT ENTANGLED IN MITRAL VALVE APPARATUS. DURING THE PROCEDURE, THE LASSO CATHETER DUE TO MANIPULATION WAS ENTANGLED IN THE MITRAL VALVE APPARATUS. IN ADDITION, THE LASSO LOOP APPEARED ON CARTO SYSTEM AS IF ON NORMAL PLANE WHILE UNDER FLUOROSCOPY, LOOP WAS DISTORTED. THE PATIENT UNDERWENT SURGICAL INTERVENTION IN ORDER TO REMOVE THE CATHETER. THE PATIENT WAS REPORTED TO BE RECOVERED AT THE TIME BWI FOLLOWED-UP WITH THE PHYSICIAN; THE PATIENT REQUIRED HOSPITALIZATION. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS PROCEDURE AND PRODUCT RELATED. THE PHYSICIAN STATED THE RISKS INVOLVED IN THIS TYPE OF PROCEDURE AND AWARE OF THE GUIDELINES WHEN USING THE LASSO CATHETER IN THE LA ANATOMY. THE INSTRUCTION FOR USE (IFU) RECOMMENDS THAT A CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. THE LASSO CATHETER IS NOT RECOMMENDED FOR USE IN THE VENTRICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679675 LASSO? 2515 VARIABLE CIRCULAR MAPPING CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1237-01-S UNKNOWN_D-1237-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R