BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® 2515 NAV VARIABLE CATHETER

    MDR report key: 1954646 · Received January 10, 2011

    Report

    Report Number
    9673241-2011-00008
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATED THAT THE INCIDENT WAS NOT RELATED TO ANY BIOSENSE WEBSTER, INC PRODUCTS AND THAT THE INJURY WAS CAUSED BY A CATHETER NOT MANUFACTURED BY BIOSENSE WEBSTER, INC. THE CATHETERS WERE DISCARDED BY THE CUSTOMER AND WERE NOT RETURNED FOR INVESTIGATION. CONCOMITANT BIOSENSE WEBSTER USED DURING THE PROCEDURE: STOCKERT 70 SYSTEM, MODEL NO.:M-5463-01, (B)(4); COOL FLOW PUMP,U.S. SHIP KIT; MODEL NO.:M-5491-02; (B)(4); CARTO 3 SYSTEM, MODEL NO.: M-4800-01, (B)(4); NAVI-STAR THERMOCOOL ELECTROPHYSIOLOGY CATHETER, CATALOG NO.:NI75TCJH, LOT NO.: 13362955; CARTO 3 EXTERNAL REFPATCH, CATALOG NO.:CREFP6, LOT NO.: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN PERFORATED THE LEFT ATRIAL ROOF WITH A ST. JUDE AGELIS SHEATH AND THAT THE EVENT OCCURRED DURING TRANS-SEPTAL AND WAS REALIZED DURING MAPPING INDICATING NONE OF THE CATHETERS WERE IN USE WHEN THE INCIDENT OCCURRED. UPON INJURY, ICE WAS USED TO CONFIRM PERFORATION. A PERICARDIOCENTESIS AND PERICARDIAL WINDOW WAS PERFORMED TO CORRECT THE INJURY. ALL BWI EQUIPMENT IN THE ROOM HAD NOTHING TO DO WITH THE CAUSE OF THE INJURY ITSELF. THE CARTO 3 SYSTEM WAS BEING USED IN CONJUNCTION WITH THE LASSO NAV CATHETER TO MAP THE ATRIAL GEOMETRY. THE STOCKERT WAS TURNED ON AND CONNECTED TO THE SYSTEM, BUT WAS NOT IN USE AT THE TIME OF INJURY. THE CFP WAS ALSO JUST POWERED ON AND NOT IN USE, JUST CONNECTED TO THE SYSTEM. THE THERMOCOOL J-CURVE CATHETER WAS CONNECTED TO THE SYSTEM, BUT NOT IN USE. THE PHYSICIAN HAD NOT YET BEGAN ABLATING. THE CATHETER WAS LYING ON THE PATIENT AND WAS NOT INSERTED IN THE PATIENT. THE REFERENCE PATCHES WERE PLACED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO® 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-02-S 15254955L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R