BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER LASSO 7FR 20MM DEFLECTABLE CIRCULAR CATHETER

    MDR report key: 901114 · Received August 22, 2007

    Report

    Report Number
    2029046-2007-00099
    Event Type
    Malfunction
    Date Received
    August 22, 2007
    Report Date
    August 22, 2007
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE STATES "THE RETROGRADE APPROACH IS CONTRAINDICATED BECAUSE OF RISK OF ENTRAPPING THE LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER IN THE LEFT VENTRICLE OR VALVULAR APPARATUS. THE LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER IS NOT RECOMMENDED FOR USE IN THE VENTRICLES.

    Description of Event or Problem · 1

    FROM PACE 2003; 26: 1774-1775, "FRACTURE OF A CIRCULAR MAPPING CATHETER AFTER ENTRAPMENT IN THE MITRAL VALVE APPARATUS DURING SEGMENTAL PULMONARY VEIN ISOLATION." THE ARTICLE REPORTED THAT DURING REMOVAL OF A BIOSENSE WEBSTER LASSO 7FR 20-MM DEFLECTABLE CIRCULAR CATHETER, THE CATHETER BECAME ENTRAPPED IN THE MITRAL VALVE APPARATUS. DURING ATTEMPTED REMOVAL OF THE ENTRAPPED CATHETER, THE CATHETER SEPARATED FROM THE SHAFT. THE REMNANTS MIGRATED TO THE ABDOMINAL AORTA WHERE IT WAS REMOVED WITH A BASKET CATHETER. THE PATIENT RECOVERED WITHOUT SEQUELAE, BUT WITH RECURRENT EPISODES OF PAROXYSMAL AF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER LASSO 7FR 20MM DEFLECTABLE CIRCULAR CATHETER ELECTROPHYSIOLOGY CATHETER DRF BIOSENSE WEBSTER, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Life Threatening| R