BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRIAL BASKET

    MDR report key: 217085 · Received April 1, 1999

    Report

    Report Number
    2020638-1999-00008
    Event Type
    Malfunction
    Date Received
    April 1, 1999
    Date of Event
    January 8, 1999
    Report Date
    March 23, 1999
    Manufacturer
    CORDIS WEBSTER INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRIOR TO INSERTION OF THE BASKET CATHETER INTO THE PT, THE PHYSICIAN DEFLECTED (TO EXPAND) AND UNDEFLECTED (TO RELAX) THE CATHETER. IT WAS REPORTED THAT THE BASKET WOULD NOT UNDEFLECT (RELAX) SUFFICIENTLY TO ALLOW EASY RETRACTION INTO THE CATHETER SHEATH. THE PHYSICIAN HAD TO USE FORCE TO RETRACT THE BASKET INTO THE SHEATH AND SUBSEQUENTY TESTED IN A SHEATH OUTSIDE THE PT BUT EXPERIENCED DIFFICULTY WHEN ATTEMPTS WERE MADE TO DRAWBACK INTO THE SHEATH. CATHETER WAS NOT USED IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIAL BASKET BASKET MAPPING CATHETER DQO CORDIS WEBSTER INC. NO INFO 806631

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO