BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 2834055 · Received November 15, 2012

    Report

    Report Number
    9673241-2012-00327
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CATHETER WAS RECEIVED IN THE LAB ON (B)(4) 2012. UPON VISUAL INSPECTION OF THE CATHETER, BWI FAILURE ANALYSIS LAB NOTED THAT THE LASSO CATHETER LOOP HAD 6 DISTAL POLES TIED INTO A KNOT ON THE DISTAL END (AS SUPPOSED TO 4 DISTAL POLES AS REPORTED BY THE CUSTOMER). THE ELECTRODE RINGS # 1 THROUGH # 6 WERE NOTED SQUASHED AND ROUGH. ELECTRODE RING # 3 WAS TORN AND SHARP. THERE WERE ALSO SOME SCRATCHES AND WRINKLES ON THE SPINE COVER. IN ADDITION BWI LAB NOTED PRESENCE OF FIBER RESIDUE AROUND THE SPINE COVER, WHICH WAS NOT REPORTED BY THE CUSTOMER. INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT WHEN THIS LASSO WAS PROGRESSING INTO THE INFERIOR PULMONARY VEIN DURING AN A-FIB CASE, THE 4 DISTAL POLES TIED INTO A KNOT. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE DISTAL END OF LASSO LOOP HAS 6 DISTAL POLES TIED INTO A KNOT. THE CATHETER WAS TESTED FOR DEFLECTION AND IT PASSED SPECIFICATIONS. THE CONTRACTION TEST WAS PERFORMED AND IT WAS FOUND OUT OF SPECIFICATIONS SINCE THE DISTAL END OF THE LOOP WAS ALREADY DAMAGED DUE TO THE KNOT. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED; HOWEVER THE ROOT CAUSE ON HOW THE KNOT OCCURRED REMAINS UNKNOWN. THE DEVICE HISTORY RECORD 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. THE IFU STATES THAT IN ORDER TO PREVENT ENTANGLEMENT OF THE CATHETER, CARE SHOULD BE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PROCEDURE WHEN THE LASSO NAV VARIABLE ECO CATHETER WAS PROGRESSING INTO THE INFERIOR PULMONARY VEIN, THE 4 DISTAL POLES OF THE CATHETER TIED INTO A KNOT. THE PHYSICIAN MANAGED TO DILATE THE TRANSSEPTAL WITH A MOBICATH AND A NON-BWI SHEATH (SL0 SHEATH). THEN PULLED THE KNOT BACK ACROSS THE SEPTUM, BACK INTO THE MOBICATH AND WAS ABLE TO REMOVE IT OUT OF THE BODY LEAVING THE MOBICATH IN THE RIGHT ATRIUM. NO PATIENT CONSEQUENCE WAS RESULTED. THE DEVICE WAS REPLACED WITH A DIFFERENT LASSO CATHETER AND THE CASE RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S 15676465L

    Patients

    Seq Age Sex Outcome Treatment
    1