BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 3240790 · Received July 22, 2013

    Report

    Report Number
    9673241-2013-00245
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 28, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE PRODUCT ANALYSIS INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING A PROCEDURE, SIGNAL NOISE WAS DETECTED IN THE LASSO 2515 NAV VARIABLE CATHETER. THE DEVICE WAS RECEIVED IN THE LABORATORY FOR ANALYSIS AND FOREIGN MATERIAL WAS OBSERVED UNDERNEATH RING # 12 MAKING THIS EVENT REPORTABLE. THE CATHETER WAS REPLACED AND THE CASE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND THAT RING #12 WAS DAMAGED AND HAD SOME WHITE PARTICLE UNDERNEATH. THIS CONDITION WAS NOT ORIGINALLY REPORTED ON THE COMPLAINT. DUE TO THE QUANTITY/MASS SIZE OF THE WHITE FOREIGN MATERIAL SPECIFICALLY OBSERVED ON THIS LASSO CATHETER, THE IDENTIFICATION OF THE TYPE OF MATERIAL WAS NOT POSSIBLE. IT IS UNKNOWN HOW THE RING WAS DAMAGED AND THE ORIGIN OF THE FOREIGN MATERIAL. INTERNAL CORRECTIVE ACTION HAS BEEN CREATED TO INVESTIGATE THIS CONDITION. CATHETER ODS WERE MEASURED AND CATHETER WAS WITHIN SPECS. THEN PER THE REPORTED EVENT, THE CATHETER WAS EVALUATED FOR ELECTRICAL RESISTANCE AND CURRENT LEAKAGE AND IT FAILED ON ELECTRODE #1. FURTHER EXAMINATION REVEALED THAT THE LEAD WIRE #1 WAS SHORTING INSIDE THE CATHETER, CAUSING THE NOISE ISSUE. THE REPORTED CUSTOMER COMPLAINT REGARDING THE NOISE HAS BEEN VERIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, SIGNAL NOISE WAS DETECTED IN THE LASSO 2515 NAV VARIABLE CATHETER. THE CATHETER WAS REPLACED AND THE CASE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES. THE DEVICE WAS RECEIVED IN THE LABORATORY FOR ANALYSIS ON (B)(4) 2013 AND FOREIGN MATERIAL WAS OBSERVED UNDERNEATH RING # 12 MAKING THIS EVENT REPORTABLE. AWARENESS DATE CHANGE TO (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341273 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-01-S 15597616L

    Patients

    Seq Age Sex Outcome Treatment
    1