BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3890039 · Received June 24, 2014

    Report

    Report Number
    9673241-2014-00231
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 7, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT THE HANDLE PISTON WAS BROKEN. THE CATHETER DID NOT DEFLECT . UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND THE HANDLE WAS FOUND IN GOOD CONDITIONS. HOWEVER, IT WAS NOTICED 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 HAD A CHEMICAL COMPOSITION OF PE AND BARIUM SULFATE. IT IS UNKNOWN HOW THE RING WAS DAMAGED AND THE ORIGIN OF THE FOREIGN MATERIAL. IN ADDITION, A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS AND RESOLVE THIS ISSUE. DUE TO THE RING 2 CONDITION, THE CATHETER OUTER DIAMETERS WERE MEASURED AND THE DEVICE WAS WITHIN SPECIFICATIONS. THEN PER THE REPORTED EVENT, A DEFLECTION AND CONTRACTION TESTS WERE PERFORMED AND THE CATHETER PASSED BOTH. 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 DAMAGE RINGS FROM LEAVING THE FACILITY. THE REPORTED CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE HANDLE¿S PISTON WAS BROKEN AND THE CATHETER DID NOT DEFLECT. THE CASE WAS COMPLETED BY CHANGING THE CATHETER WITHOUT ANY PATIENT CONSEQUENCE. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER, ON (B)(4) 2014 BWI FAILURE ANALYSIS LAB NOTED RING #2 SHARP WITH SMALL WHITE MATERIAL UNDERNEATH RING MAKING THIS EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369137 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S UNKNOWN_D-1343-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1