BEUDAMED
    FDA Adverse Event Death Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3277347 · Received August 9, 2013

    Report

    Report Number
    9673241-2013-00275
    Event Type
    Death
    Date Received
    August 9, 2013
    Date of Event
    June 29, 2013
    Report Date
    July 30, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM, MODEL #: FG-5400-00M, SERIAL #: (B)(4); STOCKERT 70 SYSTEM, MODEL #: 39D-76X, SERIAL #: UNK; COOL FLOW PUMP, MODEL #: M-5491-01, SERIAL #: UNK; C3 EXTERNAL REFERENCE PATCH, MODEL #: D-1283-02, SERIAL #: UNK; C3 ECO INTERFACE CABLE, MODEL #: D-1327-05-S, SERIAL #: UNK; C3 INTERFACE CABLE - THERAPEUTIC, MODEL #: D-1286-03-S, SERIAL #: UNK; COOLFLOW TUBING SET, MODEL #: D-1233-01-S, SERIAL #: UNK; SMART TOUCH BIDIRECTIONAL, MODEL #: D-1327-00-S, SERIAL #: UNK; THIS IS NOT A FDA APPROVED PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 8 HOURS AFTER AN ABLATION PROCEDURE THE WARD STAFF SUSPECTED A TAMPONADE AND A THORACOTOMY WAS PERFORMED. NO PERFORATION WAS FOUND, JUST SOME OOZING. IT WAS REPORTED THAT THE PATIENT DIED IN THE HOSPITAL 2 DAYS AFTER THE PROCEDURE. THE BWI DEVICES ARE NOT SUSPECTED TO BE A CONTRIBUTING FACTOR TO THE INCIDENT. MULTIPLE ATTEMPTS WERE MADE REGARDING THIS EVENT HOWEVER NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379545 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-00 UNKNOWN_D-1343-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death