BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER PREFACE SHEATH

    MDR report key: 800737 · Received December 22, 2006

    Report

    Report Number
    2029046-2006-00108
    Event Type
    Malfunction
    Date Received
    December 22, 2006
    Date of Event
    December 7, 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
    MA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD ADVISORY NOTICE, "URGENT - MEDICAL DEVICE CORRECTION PREFACE GUIDING SHEATH FIELD ADVISORY" WAS ISSUED WORLDWIDE PRIOR TO DATE OF EVENT. 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 DISTAL TIP OF THE PREFACE SHEATH HAD SEPARATED. THE DISLODGED TIP WAS DISCOVERED INSIDE THE SHEATH WHEN REMOVED FROM PT'S BODY. NO PT INJURY WAS REPORTED.

    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 13088353

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO