BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOSENSE WEBSTER LASSO 20-POLE DEFLECTABLE 7FR 20-MM CIRCULA

    MDR report key: 902605 · Received August 22, 2007

    Report

    Report Number
    2029046-2007-00097
    Event Type
    Other
    Date Received
    August 22, 2007
    Report Date
    August 22, 2007
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 HEART RHYTHM, VOL 4, NO 1, JAN 2007. THE ARTICLE DESCRIBES ENTRAPMENT OF CIRCULAR MAPPING CATHETER IN THE MITRAL VALVE OF THREE PATIENTS. PATIENT #1 (MALE) BIOSENSE WEBSTER LASSO 20-POLE DEFLECTABLE 7FR 20 MM CIRCULAR MAPPING CATHETER BECAME FIRMLY ATTACHED TO THE CHORDAE. THE CATHETER TIP WAS CUT, AND THE TANGLE WAS SCRAPED OFF THE CATHETER WITH TWEEZERS. TRANSTHORACIC ECHOCARDIOGRAPHY AFTER ONE WEEK SHOWED A MINIMAL MITRAL INSUFFICIENCY. PATIENT #2 (MALE) BIOSENSE WEBSTER LASSO 10-POLE 7FR 15-MM DEFLECTABLE CIRCULAR MAPPING CATHETER BECAME ATTACHED TO THE POSTERIOR PART OF THE MITRAL VALVE. THE TIP WAS FREED BY THE USE OF A SHEATH WHICH WAS ADVANCED OVER THE CATHETER AND PUSHED AGAINST THE MITRAL VALVE. TRANSESOPHAGEAL ECHO SHOWED A SMALL TEAR IN THE POSTERIOR VALVE LEAFLET, CAUSING A MINOR MITRAL INSUFFICIENCY. PATIENT #3 (MALE) BIOSENSE WEBSTER LASSO 10-POLE DEFLECTABLE 7FR 10-MM CIRCULAR MAPPING CATHETER BECAME ATTACHED TO THE MITRAL VALVE. THE CATHETER WAS REMOVED BY ADVANCING A SHEATH AND APPLYING TRACTION. DURING THE NEXT TWO WEEKS, THE PATIENT DEVELOPED DYSPNEA. HEART VALVE SURGERY FOUND THE ANTERIOR COMMISSURE HAD A TEAR AND WAS REPLACED USING A MECHANICAL PROSTHETIC VALVE. THE PATIENT RECOVERED UNEVENTFULLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Life Threatening| R LASSO 10-POLE DEFLECTABLE 7FR 10-MM| BIOSENSE WEBSTER LASSO 10-POLE 7FR 15-MM