BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® 2515 NAV VARIABLE CATHETER

    MDR report key: 2200514 · Received August 11, 2011

    Report

    Report Number
    9673241-2011-00084
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, BWI RECEIVED A COPY OF THE USER FACILITY MEDWATCH REPORT (B)(4) THAT WAS FILED BY THE CUSTOMER TO THE FDA DIRECTLY ON (B)(4) 2011. PATIENT WENT TO SURGERY OVER A WEEK AFTER THE PROCEDURE BECAUSE THE PATIENT CONDITION WAS UNSTABLE. THE PATIENT WAS ON OXYGEN, AWAKE, AND SPEAKING AS OF (B)(4) 2011. TWO BWI CLINICAL ACCOUNT SPECIALISTS (CAS) WERE PRESENT DURING THE EVENT. BOTH RECOMMENDED THE PHYSICIAN TO NOT PULL THE CATHETER. UNFORTUNATELY THE PHYSICIAN CHOSE TO PULL THE CATHETER, CAUSING RUPTURE OF THE CAPILLARY MUSCLE. NO OTHER DETAIL WAS PROVIDED BY THE CUSTOMER ABOUT THE PATIENT. THE CUSTOMER HAS REQUESTED SERVICE FOR THE STOCKERT GENERATOR AND THE COOLFLOW PUMP AS A PREVENTIVE MEASURE. THERE WAS NO MALFUNCTION REPORTED FOR ANY OF THE BWO PRODUCTS AND NO ABLATIONS WERE PERFORMED ON (B)(4) 2011 ON THIS PATIENT. THE CATHETERS INVOLVED IN THIS EVENT WERE DISCARDED AND WILL NOT BE RETURNED TO BWI FOR ANALYSIS. IF THE CATHETER IS RETURNED TO BWI FOR ANALYSIS, AN INVESTIGATION WILL BE PERFORMED AND A 3500A SUPPLEMENTAL WILL BE SUBMITTED TO THE FDA AS REQUIRED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, CATALOG # FG540000, (B)(4); COOLFLOW IRRIGATION PUMP, CATALOG # CFP002, (B)(4); STOCKERT RF GENERATOR, CATALOG # S7001, (B)(4); EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER, CATALOG # BNI75TCDFH, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB ABLATION PROCEDURE, THE "LASSO 2515 NAV VARIABLE CATHETER" BECAME ENTANGLED AT THE TRICUSPID VALVE WHEN THE PHYSICIAN WAS POSITIONING THE CATHETER FROM LEFT TO RIGHT SIDE OF HEART. THE PHYSICIAN MET RESISTANCE IN RETRIEVING THE CATHETER SO A CARDIOVASCULAR SURGEON WAS CONSULTED AND A BEDSIDE 3D ECHO WAS PERFORMED. PER THE SURGEON'S SUGGESTION, THE CATHETER WAS REMOVED UNDER ECHO GUIDANCE. THE DEVICE WAS EVENTUALLY REMOVED BUT WITH RUPTURE OF THE PAPILLARY MUSCLE PER THE PHYSICIAN. THE PATIENT WAS TRANSFERRED TO THE CICU SINCE THE PATIENT UNABLE TO HAVE THE SURGERY DUE TO LOW PLATELET COUNT. THE PATIENT REQUIRES FURTHER ABLATION AND REPAIR OF THE SHUNT AND TRICUSPID VALVE.

    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-1290-01-S 15400161L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R