BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3051454 · Received April 10, 2013

    Report

    Report Number
    9673241-2013-00100
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, THE CUSTOMER LOST VISUALIZATION OF THE LASSO ECO LOOP AND THE SHAFT WAS STILL VISIBLE. THE CLINICAL ACCOUNT SPECIALIST CHANGED THE DONGLE, CABLE AND THE LASSO CATHETER AND REBOOTING THE SYSTEM. A CHEST PATCH MAGNETIC DISTORTION ERROR APPEARED AND VERIFIED THAT THE MATRIX WAS NOT BEING BUILT. ONCE MATRIX WAS REBUILT, LASSO LOOP REAPPEARED AND VISUALIZED AS EXPECTED. THE CASE COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT RING 1 WAS DAMAGED AND HAD A SHARP EDGE. THIS CONDITION WAS NOT REPORTED ON THE ORIGINAL COMPLAINT. THE OUTER DIAMETERS OF THE CATHETER WERE MEASURED AND ALL WERE FOUND WITHIN SPECIFICATION. THE DEVICE HISTORY RECORD COULD NOT BEEN REVIEWED SINCE THE LOT # OF THIS PRODUCT WAS NOT PROVIDED WHEN EVENT REPORTED. 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. NO FURTHER TEST WAS PERFORMED TO THE CATHETER SINCE IT WAS A REPLACEMENT DUE TO TROUBLESHOOTING IN HARDWARE SYSTEM.

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCT: CARTO 3: MODEL# M-4800-01, SERIAL # (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, THE CUSTOMER LOST VISUALIZATION OF THE LASSO ECO LOOP AND THE SHAFT WAS STILL VISIBLE. THE CLINICAL ACCOUNT SPECIALIST CHANGED THE DONGLE, CABLE AND THE LASSO CATHETER AND REBOOTING THE SYSTEM. A CHEST PATCH MAGNETIC DISTORTION ERROR APPEARED AND VERIFIED THAT THE MATRIX WAS NOT BEING BUILT. ONCE MATRIX WAS REBUILT, LASSO LOOP REAPPEARED AND VISUALIZED AS EXPECTED. THE CASE COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. ON (B)(6) 2013, UPON RECEIVING THE PRODUCT IN BIOSENSE WEBSTER LAB, IT WAS NOTICED THAT RING #1 WAS DAMAGED AND SHARP ON THE PROXIMAL SIDE MAKING THIS EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153725 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S UNKNOWN_D-1343-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1