BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3970511 · Received July 31, 2014

    Report

    Report Number
    9673241-2014-00287
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    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
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THE PRODUCT INVESTIGATION IS PENDING. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THE REPORTED LOT NUMBER IS 16077233L. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT THE CATHETER HAD A DEFECTED POLE (NUMBER 3). THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED FOR CLARIFICATION FOR THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION WAS MADE AVAILABLE. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND THAT ELECTRODE RING 10 WAS DAMAGED. THIS CONDITION WAS NOT ORIGINALLY REPORTED ON THE COMPLAINT. IT IS UNKNOWN HOW THE ELECTRODE RING WAS DAMAGED. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THIS ISSUE. THE CATHETER OUTER DIAMETERS WERE MEASURED AND THE DEVICE WAS WITHIN SPECIFICATIONS. THE ELECTRODE RING 3 WAS NOT DAMAGED AND IT WAS ELECTRICALLY WORKING ACCORDINGLY. THE ELECTRODE RING 10 FAILED THE ELECTRICAL TEST DUE TO THE CONDITION FOUND AND INITIALLY STATED. 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. ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED RINGS FROM LEAVING THE FACILITY. THE REPORTED CUSTOMER COMPLAINT CANNOT BE CONFIRMED. FOR THE DAMAGED ELECTRODE RING, AS PREVIOUSLY STATED, AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT A PROCEDURE WITH A LASSO NAVIGATIONAL VARIABLE ECO CATHETER. A DAMAGED ELECTRODE RING MALFUNCTION OCCURRED. IT WAS REPORTED THAT THE CATHETER HAD A DEFECTED POLE (NUMBER 3). THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED FOR CLARIFICATION FOR THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION WAS MADE AVAILABLE. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER ON JULY 11, 2014, THE BWI FAILURE ANALYSIS LAB NOTED THAT THE ELECTRODE RING #10 WAS TORN AND SHARP. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE. HOWEVER, THE RETURNED CATHETER CONDITION NOTED ON JULY 11, 2014 HAS BEEN ASSESSED AS REPORTABLE. THE AWARENESS DATE WAS UPDATED FOR THIS RECORD FROM JUNE 12, 2014 TO JULY 11, 2014 AS WHEN THE ISSUE WAS FOUND FROM THE BWI FAILURE ANALYSIS LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447551 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-02-S UNKNOWN_D-1343-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1