BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER PREFACE SHEATH

    MDR report key: 800774 · Received December 22, 2006

    Report

    Report Number
    2029046-2006-00109
    Event Type
    Malfunction
    Date Received
    December 22, 2006
    Date of Event
    December 6, 2006
    Report Date
    December 22, 2006
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DYB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS PREVIOUSLY AWARE OF THE "URGENT - MEDICAL DEVICE CORRECTION PREFACE GUIDING SHEATH FIELD ADVISORY". IFU STATES UNDER PRECAUTIONS: "DO NOT ATTEMPT TO ADVANCE OR WITHDRAW THE GUIDEWIRE AND/OR CATHETER SHEATH INTRODUCER IF RESISTANCE IS FELT. STOP THE PROCEDURE AND USE FLUOROSCOPY TO DETERMINE THE CAUSE. IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING INTRODUCTION, USE A 10F OR LARGER INTRODUCER."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE FOUND A MISSING TIP ON THE PREFACE SHEATH DURING CLEANING OF THE TABLE. FLUOROSCOPE AND CT SCAN WAS USED TO SEARCH THE WHOLE BODY FOR THE TIP, BUT NO TIP WAS FOUND INSIDE. IT IS UNKNOWN WHERE THE TIP HAD SEPARATED AS IT COULD NOT BE FOUND. IT WAS REPORTED THAT NO ADVERSE EVENT OCCURRED WITH THE PT. IT WAS REPORTED THAT A BOSTON SCIENTIFIC EPT CATHETER WAS USED WITH THE PREFACE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER PREFACE SHEATH BRAIDED GUIDING SHEATH DYB BIOSENSE WEBSTER, INC. D-1215-01-S 13076034

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO