BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® NAV ECO VARIABLE CATHETER

    MDR report key: 2719119 · Received August 29, 2012

    Report

    Report Number
    9673241-2012-00237
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    July 25, 2012
    Report Date
    July 25, 2012
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON THE DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND THAT RINGS 1 AND 20 WERE DAMAGED. THIS CONDITION WAS NOT ORIGINALLY REPORTED ON THE COMPLAINT AND IT IS UNKNOWN HOW THE RING WAS DAMAGED. PER THE REPORTED EVENT, THE CATHETER WAS EVALUATED UNDER DEFLECTION AND CONTRACTIONS TEST AND IT PASSED, IN ADDITION THE OUTER DIAMETER (OD) RINGS WERE MEASURED AND THEY WERE FOUND WITHIN SPECIFICATION. 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 REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. FURTHER INVESTIGATION REGARDING THIS ISSUE FOUND AT BWI FAILURE ANALYSIS LAB THAT WAS NOT REPORTED IN THE COMPLAINT RESULTED IN AN INTERNAL CORRECTIVE ACTION THAT WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, THE LASSO CATHETER STOPPED DEFLECTING DURING THE PROCEDURE. THE CATHETER WAS IN THE LEFT ATRIUM AT THE TIME OF THE ISSUE. THERE WAS NO DIFFICULTY TO REMOVE THE CATHETER FROM THE PATIENT. THE CASE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE BY REPLACING THE CATHETER. DURING VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER ON (B)(4) 2012, IT WAS NOTED THAT ELECTRODE RINGS WERE DAMAGED AND HAD ROUGH EDGES. THIS CONDITION WAS NOT REPORTED BY THE CUSTOMER. THE ELECTRODE RING DAMAGE CONDITION IS INDICATIVE OF A REPORTABLE EVENT, THUS MARKING (B)(4) 2012 AS THE ALERT DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO® NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S 15551944L

    Patients

    Seq Age Sex Outcome Treatment
    1