BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3232930 · Received July 18, 2013

    Report

    Report Number
    9673241-2013-00237
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED THAT THIS CATHETER DISPLAYED THE BAD LOCATION SENSOR ERROR. THE CABLE WAS EXCHANGED WITH NO RESOLUTION. ISSUE WAS RESOLVED AFTER THE CATHETER WAS EXCHANGED. ON 07/03/2013, THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND THE CATHETER RING #1 WAS SQUASHED AND SHARP. SPINE COVER AND RINGS #9 & #10 WERE SQUASHED. THIS CONDITION WAS NOT ORIGINALLY REPORTED. DUE TO THE CATHETER¿S CONDITION, THIS IS NOW A MDR REPORTABLE EVENT. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND THE RING #1 WAS SQUASHED AND SHARP. SPINE COVER AND RINGS #9 AND #10 WERE ALSO SQUASHED. THIS CONDITION WAS NOT ORIGINALLY REPORTED ON THE COMPLAINT. IT IS UNKNOWN HOW THE RING #1 WAS DAMAGED. A CORRECTIVE ACTION HAS BEEN CREATED TO INVESTIGATE THIS CONDITION. CATHETER ODS WERE MEASURED AND CATHETER WAS WITHIN SPECIFICATIONS. THEN PER THE REPORTED EVENT, THE CATHETER WAS TESTED ON EEPROM AND CALIBRATION TEST AND THE CATHETER PASSED EEPROM TEST BUT FAILED CALIBRATION TEST. THE CATHETER WAS THEN DISSECTED AND IT WAS DETERMINED THAT THE ROOT CAUSE WAS AN INTERNAL FAILURE OF THE SENSOR CABLE. 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 ON REGARDS THE BAD LOCATION SENSOR ERROR HAS BEEN VERIFIED. FOR THE DAMAGE RING, AS PREVIOUSLY STATED, A CORRECTIVE ACTION HAS BEEN CREATED.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED THAT THIS CATHETER DISPLAYED THE BAD LOCATION SENSOR ERROR. THE CABLE WAS EXCHANGED WITH NO RESOLUTION. ISSUE WAS RESOLVED AFTER THE CATHETER WAS EXCHANGED. ON (B)(6) 2013, THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND THE CATHETER RING #1 WAS SQUASHED AND SHARP. SPINE COVER AND RINGS #9 & #10 WERE SQUASHED. THIS CONDITION WAS NOT ORIGINALLY REPORTED. DUE TO THE CATHETER¿S CONDITION, THIS IS NOW A MDR REPORTABLE EVENT. THE ALERT DATE WAS RESET TO (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333960 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S 15863888L

    Patients

    Seq Age Sex Outcome Treatment
    1