BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3812260 · Received May 15, 2014

    Report

    Report Number
    9673241-2014-00193
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A) PENDING ADDITIONAL INFORMATION FROM THE ANALYSIS RESULTS THAT WERE SUBMITTED ON JULY 1ST AS A SUPPLEMENTAL # 1 (9673241-2014-00193): THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. AS FOR THE DAMAGE RING/FOREIGN PARTICLES FOUND ON THE PRODUCT RETURNED, AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE IT. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4) DURING AN ATRIAL FIBRILLATION PROCEDURE, IT WAS REPORTED THAT MAGNETIC DISTORTION AND MAGNETIC SENSOR ERROR WERE BEING DISPLAYED ON THE CARTO 3 SYSTEM. TROUBLESHOOTING WAS PERFORMED WITH NO RESOLUTION: REPLACING THE CABLE WITH A BRAND NEW CABLE TWO TIMES AND REPLACING THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY (CONVENTIONALLY) WITH NO PATIENT CONSEQUENCES. THE CUSTOMER REQUESTED REPLACEMENT FOR THE CABLES AND CATHETER USED DURING TROUBLESHOOTING. ON MAY 5TH, FAILURE ANALYSIS LAB FOUND WHITE FOREIGN MATERIAL UNDERNEATH RING # 2 ON THE PROXIMAL SIDE OF THE LASSO NAV ECO VARIABLE CATHETER. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND FOUND THAT RING # 2 WAS DAMAGED AND HAD SOME WHITE PARTICLE UNDERNEATH. THIS CONDITION WAS NOT ORIGINALLY REPORTED ON THE COMPLAINT. A FT-IR TEST WAS PERFORMED TO IN ORDER TO IDENTIFY THE TYPE OF FOREIGN MATERIAL, THE RESULTS DEMONSTRATED THAT THE PARTICLE IS MAINLY COMPOSED OF POLYETHYLENE AND BARIUM SULFATE. IT IS UNKNOWN HOW THE RING WAS DAMAGED AND THE ORIGIN OF THE FOREIGN MATERIAL. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE AND ADDRESS THIS TYPE OF ISSUE. CATHETER ODS WERE MEASURED AND THE DEVICE WAS WITHIN SPECIFICATIONS. PER THE REPORTED EVENT, THE CATHETER WAS EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVESTIGATION IS STILL IN PROGRESS. (B)(4).

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION PROCEDURE, IT WAS REPORTED THAT MAGNETIC DISTORTION AND MAGNETIC SENSOR ERROR WERE BEING DISPLAYED ON THE CARTO 3 SYSTEM. TROUBLESHOOTING WAS PERFORMED WITH NO RESOLUTION: REPLACING THE CABLE WITH A BRAND NEW CABLE TWO TIMES AND REPLACING THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY (CONVENTIONALLY) WITH NO PATIENT CONSEQUENCES. THE CUSTOMER REQUESTED REPLACEMENT FOR THE CABLES (CARTO® 3 SYSTEM ECO INTERFACE CABLE) AND CATHETER USED DURING TROUBLESHOOTING (LASSO® NAV ECO VARIABLE CATHETER) ON (B)(4), FAILURE ANALYSIS LAB FOUND WHITE FOREIGN MATERIAL UNDERNEATH RING # 2 ON THE PROXIMAL SIDE OF THE LASSO® NAV ECO VARIABLE CATHETER. DUE TO THIS FINDING AND THE POTENTIAL RISK TO THE PATIENT, IT WAS DETERMINED FOR THIS COMPLAINT TO BE REPORTABLE. AWARENESS DATE CHANGED FROM (B)(6) 2014

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291943 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S 16050302L

    Patients

    Seq Age Sex Outcome Treatment
    1