BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3854423 · Received June 6, 2014

    Report

    Report Number
    9673241-2014-00217
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE LASSO NAV CATHETER GOT HUNG UP ON THE SHEATH WHEN THE PHYSICIAN WAS PULLING IT OUT OF THE LA. THE PHYSICIAN HAD TO PULL EXTREMELY HARD TO GET THE CATHETER TO COME THROUGH THE SHEATH. WHEN THE CATHETER WAS REMOVED ONE ELECTRODE WAS BENT ABOUT HALF A MILLIMETER. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND THAT RING 1 WAS DAMAGED. . IN ADDITION, A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS AND RESOLVE THIS ISSUE. THE CATHETER ODS WERE MEASURED AND IT WAS FOUND WITHIN SPECIFICATIONS. THEREFORE, IT REMAINS UNKNOWN THE ORIGIN OF THE CATHETER HANGING. 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 HAS BEEN VERIFIED. HOWEVER, IT REMAINS UNKNOWN HOW THE ISSUE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE LASSO NAV CATHETER GOT HUNG UP ON THE SHEATH WHEN THE PHYSICIAN WAS PULLING IT OUT OF THE LEFT ATRIUM. THE PHYSICIAN HAD TO PULL EXTREMELY HARD TO GET THE CATHETER TO COME THROUGH THE SHEATH. WHEN THE CATHETER WAS REMOVED, ONE ELECTRODE WAS BENT ABOUT HALF A MILLIMETER. THE CASE RESUMED WITHOUT ANY PATIENT CONSEQUENCE. UPON RECEIVING THE PRODUCT IN BIOSENSE WEBSTER LAB, IT WAS NOTICED THAT RING #1 TORN, SHARP STICKING OFF RING ABOUT 1.8 CM, MAKING THIS EVENT REPORTABLE. INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332549 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