BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 3051455 · Received April 10, 2013

    Report

    Report Number
    9673241-2013-00101
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO EVALUATION SUMMARY. (B)(4). UPON RECEIVING, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE COMPLAINT, THE CATHETER WAS TESTED FOR DEFLECTION AND THE CATHETER FAILED. AFTERWARDS, THE ANCHOR WINDOW WAS INSPECTED AND IT WAS NOTICED THE T BAR WAS NOT VISIBLE. WHILE DOING THIS IT WAS OBSERVED THAT THE PU IN ANCHOR WINDOW WAS DAMAGED AT THE MIDDLE. SOME BROWNISH MATERIAL WAS INSIDE THE ANCHOR WINDOW AS WELL. AFTER FURTHER INSPECTION, IT WAS NOTICED THAT THE T BAR TORE OFF THE ANCHOR WINDOW PU ALONG WITH THE SOFT TIP CAVITY WHERE THE ANCHOR WINDOW LIES. THIS CREATED A SPACE WHICH WEAKENED THE ANCHOR WINDOW AREA, CAUSING THE PU TO EITHER PEEL OFF OR CRACK. THE T BAR FALLING OFF ISSUES HAVE BEEN ADDRESSED UNDER AN INTERNAL CORRECTIVE ACTION. 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. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, WHEN THE LASSO CATHETER WAS USED IN THE PATIENT, THE OPERATOR REALIZED THAT THE CATHETER WAS NOT DEFLECTING. DEFLECTION WAS NOT TESTED BEFORE INSERTING OF THE CATHETER IN THE PATIENT. THE CATHETER WAS REMOVED FOR THE PATIENT WITHOUT ANY DIFFICULTY. THE CASE WAS COMPLETED BY CHANGING THE SAME LIKE CATHETER WITHOUT ANY PATIENT CONSEQUENCE. ON (B)(6) 2013, UPON RECEIVING THE PRODUCT IN BIOSENSE WEBSTER LAB, IT WAS NOTICED THAT THE ANCHOR WINDOW WAS DAMAGED AND HAD BROWNISH MATERIAL INSIDE MAKING THIS EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148452 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-02-S 15723825L

    Patients

    Seq Age Sex Outcome Treatment
    1