BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 3060220 · Received April 16, 2013

    Report

    Report Number
    9673241-2013-00105
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 14, 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
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE IN THE LEFT CHAMBER, THERE WAS A DEFLECTION MECHANISM DEFECT AFTER AN HOUR AND THIRTY MINUTES. THE C3 NAVIGATIONAL VARIABLE LASSO CATHETER WAS NOT ABLE TO DEFLECT. THERE WAS NO PROBLEM REMOVING THE CATHETER. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED BY THE BWI FIELD REPRESENTATIVE. IT WAS CONFIRMED THAT THERE WERE NO PATIENT CONSEQUENCES AND THAT THE PROCEDURE WAS COMPLETED BY EXCHANGING THE CATHETER. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER, THE BWI FAILURE ANALYSIS LAB NOTED THAT THE ELECTRODE RING #1 WAS FOLDED OVER ON THE PROXIMAL SIDE WITH A GAP. ADDITIONAL INFORMATION ON THE RETURNED CATHETER CONDITION HAS BEEN REQUESTED BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT ELECTRODE RING #1 WAS LIFTED AND FOLDED ON THE PROXIMAL SIDE. THIS CONDITION WAS NOT REPORTED ON THE ORIGINAL COMPLAINT. THE OUTER DIAMETERS OF THE PU WERE MEASURED AND FOUND WITHIN SPECIFICATION. THEN PER THE REPORTED EVENT, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED ALL TESTS. THE CATHETER WAS DISSECTED AND IT WAS FOUND THAT THE T-BAR SLID DOWN THE LUMEN CAUSING THE DEFLECTION ISSUE. 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. 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. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED. INTERNAL CORRECTIVE ACTIONS HAVE BEEN OPENED TO ADDRESS THE T-BAR ISSUE AND THE RING DAMAGE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE IN THE LEFT CHAMBER, THERE WAS A DEFLECTION MECHANISM DEFECT AFTER AN HOUR AND THIRTY MINUTES. THE C3 NAVIGATIONAL VARIABLE LASSO CATHETER WAS NOT ABLE TO DEFLECT. THERE WAS NO PROBLEM REMOVING THE CATHETER. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED BY THE BWI FIELD REPRESENTATIVE. IT WAS CONFIRMED THAT THERE WERE NO PATIENT CONSEQUENCES AND THAT THE PROCEDURE WAS COMPLETED BY EXCHANGING THE CATHETER. THE INITIAL REPORTED COMPLAINT ITSELF WAS NOT INDICATIVE OF A REPORTABLE EVENT BECAUSE THE COMPLAINT ISSUE WAS HIGHLY DETECTABLE WITHOUT ANY PATIENT CONSEQUENCE. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER ON (B)(6) 2013, THE BWI FAILURE ANALYSIS LAB NOTED THAT THE ELECTRODE RING #1 WAS FOLDED OVER ON THE PROXIMAL SIDE WITH A GAP. ADDITIONAL INFORMATION ON THE RETURNED CATHETER CONDITION HAS BEEN REQUESTED BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS RETURNED CATHETER CONDITION IS INDICATIVE OF A REPORTABLE EVENT, THUS MARKING (B)(4) 2013 AS THE ALERT DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163434 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-02-S 15712829L

    Patients

    Seq Age Sex Outcome Treatment
    1