BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 2842872 · Received November 21, 2012

    Report

    Report Number
    9673241-2012-00339
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K113213
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED IN THE MIDDLE OF THE ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE LASSO NAV ECO VARIABLE CATHETER GOT STUCK IN THE MITRAL VALVE IN THE LEFT ATRIUM TO THE LEFT VENTRICLE. AFTER APPROXIMATELY 45 MINUTES, THIS CATHETER WAS SUCCESSFULLY REMOVED, BUT IT WAS COMPLETELY TANGLED AND BENT IN HALF. THE ELECTRODE WAS EXPOSED CAUSED BY THE MANIPULATION. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE LASSO NAV ECO VARIABLE CATHETER LOOP WAS BROKEN IN HALF BETWEEN THE ELECTRODE RINGS 10 AND 11 AND THE NITINOL WIRE WAS EXPOSED THROUGH THE COIL AND SPINE COVER. ELECTRODE RINGS 2, 3 AND 4 AND THE SPINE COVER WERE FOUND SQUASHED. A WRINKLE BETWEEN ELECTRODE RINGS 19 AND 20 WAS ALSO OBSERVED. NO FURTHER TEST COULD BE PERFORMED DUE TO THE DAMAGE TO THE LOOP DURING THE MANIPULATION OF THE CATHETER UPON WITHDRAWING. HOWEVER, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. CATHETER ADVANCEMENT AND PLACEMENT SHOULD BE DONE UNDER FLUOROSCOPIC GUIDANCE THROUGH A GUIDING SHEATH.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: MODEL # M-4800-01, SERIAL # (B)(4); STOCKERT 70 SYSTEM: MODEL #: M-5463-01, SERIAL #: (B)(4); COOL FLOW PUMP,U.S. SHIP KIT: MODEL #: M-5491-02, SERIAL #(B)(4); THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER: MODEL #: D-1313-04-S, LOT #: 15665805L. PER THE BWI FIELD REPRESENTATIVE, THIS CATHETER WILL BE FORWARDED TO THE BWI FAILURE ANALYSIS LAB FOR INVESTIGATION; EZ STEER THERMOCOOL SF NAV: MODEL #: D-1317-00, LOT # UNKNOWN; PER THE BWI FIELD REPRESENTATIVE, THIS CATHETER HAS BEEN DISCARDED. REGARDING THE BIOSENSE WEBSTER SYSTEMS, THE CUSTOMER WAS CONTACTED BY BWI FIELD SERVICE ENGINEER. THE HOSPITAL EP LAB STAFF ADVISED THAT THIS ISSUE WAS NOT RELATED TO BWI SYSTEMS. THE CUSTOMER DECLINED SYSTEM SERVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE BEGINNING OF AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, WHILE CONNECTING THE EZ STEER THERMOCOOL SF NAV CATHETER (LOT#15665805L), IT WAS NOTICED THAT THE PIN CONNECTOR AT THE HUB WAS BENT. THE CATHETER WAS EXCHANGED WITH EZ STEER THERMOCOOL SF NAV CATHETER (UNKNOWN CATALOG# AND LOT#) AND THE CASE WAS RESUMED. IT WAS ALSO REPORTED THAT IN THE MIDDLE OF THE PROCEDURE, THE LASSO NAV ECO VARIABLE CATHETER GOT STUCK IN THE MITRAL VALVE IN THE LEFT ATRIUM TO THE LEFT VENTRICLE. WHEN THIS CATHETER WAS MANIPULATED OUT, THE ELECTRODE WAS EXPOSED CAUSED BY THE MANIPULATION. THEY WERE ABLE TO REMOVE THIS CATHETER AND THERE WAS NO MEDICAL INTERVENTION ADMINISTERED TO THE PATIENT. THE PATIENT WAS STABLE AND ADMITTED FOR OBSERVATION. THE BWI FIELD REPRESENTATIVE SAID THAT IT WAS NOT REALLY AN INJURY RIGHT NOW, BUT THE PATIENT WAS ADMITTED AND IS BEING MONITORED BECAUSE THEY NOTICED THAT SOMETHING WAS WRONG WITH THE PATIENT'S MITRAL VALVE BEHAVIOR. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE EVENT WAS LIFE THREATENING. AT LAST CHECK THERE WAS IMPAIRMENT OF THE MITRAL VALVE. THE LASSO NAV ECO VARIABLE CATHETER WAS CAUGHT IN THE MITRAL VALVE APPARATUS. AFTER APPROXIMATELY 45 MINUTES, THIS CATHETER WAS SUCCESSFULLY REMOVED, BUT IT WAS COMPLETELY TANGLED AND BENT IN HALF. THE PATIENT WAS BEING MONITORED FOR AN EXTRA DAY AT THE HOSPITAL. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND IS FULLY RECOVERED (NO RESIDUAL EFFECTS). CAUSALITY OF THE EVENT IS THAT IT WAS DEVICE RELATED. THE PHYSICIAN CONSIDERS THAT THE EVENT'S CAUSALITY WAS DUE TO THIS CATHETER BEING CAUGHT IN THE MITRAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S 15697561L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L