BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3169866 · Received June 14, 2013

    Report

    Report Number
    9673241-2013-00191
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K113213
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4). EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER: MODEL #: D-1313-05-S, LOT #: 15759362L. SOUNDSTAR CATHETER: MODEL #: M-5723-05, LOT #: OEM_M-5723-05. COOLFLOW PUMP: MODEL #: M-5491-02, SERIAL #: (B)(4). STOCKERT 70 SYSTEM: MODEL #: M-5463-01, SERIAL #: (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE EVENT WAS NOT LIFE THREATENING. THE EVENT DID NOT RESULT IN AN IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO THE BODY STRUCTURE. WHILE MAPPING THE LEFT ATRIUM FOR AN ATRIAL FIBRILLATION PULMONARY VEIN ISOLATION PROCEDURE WITH THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER, THE AFOREMENTIONED CATHETER ENTERED THE LEFT VENTRICLE WHERE IT COULD NOT BE EXTRACTED DUE TO ENTANGLEMENT WITHIN A MITRAL VALVE APPARATUS. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR EXTRACTION OF THE CATHETER. THE EVENT DID REQUIRE EXTENDED HOSPITAL STAY. THE OUTCOME OF THE ADVERSE EVENT WAS THAT THE PATIENT FULLY RECOVERED. THE PROGNOSIS WAS THAT THE PATIENT FULLY RECOVERED WITH NO FURTHER ISSUES. CAUSALITY OF THE ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. FIXED QUAD CATHETERS WERE REPROCESSED. THE PATIENTS UPDATED HEALTH STATUS WAS GOOD. THE OUTCOME THAT ATTRIBUTED TO THE EVENT WAS THORACOTOMY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. THE DEVICE HISTORY RECORD (DHR)WAS REVIEWED. THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER BECAME ENTRAPPED IN THE MITRAL VALVE. AT THE TIME OF THE CALL, THE FOLLOWING HAD BEEN DONE TO ATTEMPT TO DISLODGE THE CATHETER: SHEATH WAS ADVANCED, CATHETER WAS ROTATED CLOCKWISE, AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS USED TO VISUALIZE ENTANGLEMENT. ALL ATTEMPTS FAILED, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF THE CATHETER. THE BWI FIELD REPRESENTATIVE STATED THAT THE PATIENT WAS STABLE AND THERE WAS NO DAMAGE TO THE MITRAL VALVE AT THAT POINT. CLARIFICATION ON THE EVENT WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270580 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-02-S 15771014L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R