BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO? ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3973827 · Received August 1, 2014

    Report

    Report Number
    9673241-2014-00289
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K002333
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. (B)(4). 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 ADDRESS THIS CONDITION. THE CATHETER OUTER DIAMETERS WERE MEASURED AND THE DEVICE WAS WITHIN SPECIFICATIONS. THEN PER THE REPORTED EVENT, AN ELECTRICAL TEST WAS PERFORMED AND CATHETER PASSED. 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 THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. THE REPORTED CUSTOMER COMPLAINT CANNOT BE CONFIRMED. FOR THE DAMAGE RING, AS PREVIOUSLY STATED, AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A LASSO CATHETER. A DAMAGED ELECTRODE RING MALFUNCTION OCCURRED. IT WAS REPORTED THAT THIS CATHETER WAS NOT DISPLAYED ON THE VELOCITY MAPPING SYSTEM. IT WAS ALSO REPORTED THAT NOISE FROM THIS CATHETER WAS BEING DISPLAYED ON THE VELOCITY MAPPING SYSTEM AND ON THE RECORDING SYSTEM. THE CATHETER WAS REPLACED AND THE ISSUES WERE RESOLVED. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER ON JULY 11, 2014, THE BWI FAILURE ANALYSIS LAB NOTED THAT THE ELECTRODE RING #10 WAS DAMAGED AND WAS SHARP ON THE DISTAL SIDE. ADDITIONAL INFORMATION WAS REQUESTED FOR CLARIFICATION ON THIS RETURNED CATHETER CONDITION. HOWEVER, NO FURTHER INFORMATION WAS MADE AVAILABLE. 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 3, 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
    450442 LASSO? ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1220-39-S 16064669L

    Patients

    Seq Age Sex Outcome Treatment
    1