BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3233228 · Received July 18, 2013

    Report

    Report Number
    9673241-2013-00239
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K113213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE PRODUCT ANALYSIS INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

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¿S WERE MEASURED AND CATHETER WAS FOUND WITHIN SPECIFICATIONS. THEN PER THE REPORTED EVENT, AN ELECTRICAL TEST WAS PERFORMED AND CATHETER PASSED. THE REPORTED CUSTOMER COMPLAINT CANNOT BE CONFIRMED. 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. IN ADDITION, ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334422 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S 15858060L

    Patients

    Seq Age Sex Outcome Treatment
    1