BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 1932916 · Received December 20, 2010

    Report

    Report Number
    2029046-2010-00071
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED CATHETER WAS TESTED AND PASSED DEFLECTION TEST, HOWEVER FAILED THE CONTRACTION TEST. THE FAILURE WAS DUE TO THE ANGLED LASSO CATHETER WHEN WAS FULLY CONTRACTED, CAUSED BY THE LEAD WIRES WRAPPING AROUND THEMSELVES. NOTE: CATHETER WAS RETURNED WITH A BUMP IN THE SPINE COVER MATERIAL,WHICH COULD BE CAUSED BY HANDLING. THE DEVICE HISTORY RECORD 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. COMPLAINT CONDITION WAS NOT CONFIRMED. HOWEVER THE CATHETER HAD A BUMP IN THE SPINE COVER MATERIAL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CLOT WAS NOTED FROM THE ULTRA SOUND OF A PROCEDURE. THE SIZE OF CLOT WAS UNKNOWN. IT IS UNCLEAR IF THE CLOT CAN BE DISLODGED OR NOT. THE CASE WAS ABORTED. A NEUROLOGIST HAD BE CONSULTED REGARDING THIS MATTER. NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS CASE OR PATIENT, SUCH AS THE TYPE OF PROCEDURE PERFORMED, PATIENT INFORMATION (AGE/ GENDER/ CO-CONDITION). IT IS ALSO UNKNOWN WHETHER THE PATIENT WAS ON ANY ANTICOAGULANT, OR IF A TRANS THORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED PRIOR TO THE PROCEDURE TO DETERMINE IF CLOT WAS ALREADY PRESENT PRIOR TO THE PROCEDURE OR IF PROLONGED HOSPITALIZATION WAS REQUIRED BECAUSE OF THE CASE CANCELLATION. THE BWI REPRESENTATIVE WAS NOT PRESENT DURING THE CASE.

    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 (IRWINDALE) D-1290-02-S UNKNOWN_D-1290-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1