BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER

    MDR report key: 1070549 · Received July 1, 2008

    Report

    Report Number
    2029046-2008-00028
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 13, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC.(IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K002333
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL EVENT DESCRIPTION PROVIDED WAS NOT INDICATIVE OF A REPORTABLE COMPLAINT. UPON EVAL OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT IT IS A REPORTABLE MALFUNCTION. EVAL OF THE PRODUCT WAS COMPLETED ON 06/03/2008. INVESTIGATION RESULTS INDICATED THAT THE CUSTOMER EXPERIENCED RESISTANCE WHILE THE PRODUCT WAS WITHDRAWN, AND IT IS POSSIBLE THAT THE RING ELECTRODE WAS CAUGHT WITH THE EDGE OF THE SHEATH'S TIP CAUSING THE DAMAGE ON THE RING. DURING THE VISUAL INSPECTION OF THE CATHETER, IT WAS NOTICED THAT THE ELECTRODE RING #1 WAS LIFTED UP LEAVING THE RING ELECTRODE TO HAVE A SHARP EDGE, INDICATING THAT AN EXCESSIVE FORCE WAS APPLIED. THE PU MARGIN OF ELECTRODE RING #1 WAS DAMAGED FROM THE EDGE OF THE RING. THE PU MARGINS WERE FOUND TO BE WITHIN SPEC. THE SHEATH INTRODUCER WAS NOT RETURNED. IN ADDITION, A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS AND RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PROCEDURE, THE CUSTOMER HAD DIFFICULTY RETRIEVING THE CATHETER FROM THE PT. EVENTUALLY THEY SUCCEEDED TO RETRIEVE THE CATHETER BY FORCE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC.(IRWINDALE) D-1220-38-S UNKNOWN_D-1220

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK