BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER PREFACE SHEATH

    MDR report key: 800746 · Received December 22, 2006

    Report

    Report Number
    2029046-2006-00107
    Event Type
    Malfunction
    Date Received
    December 22, 2006
    Date of Event
    December 1, 2006
    Report Date
    December 14, 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 INFORMED ABOUT THE "URGENT - MEDICAL DEVICE CORRECTION PREFACE GUIDING SHEATH FIELD ADVISORY" ON 11/28/06, WHICH WAS PRIOR TO THE DATE OF EVENT. IT WAS REPORTED THAT REGARDLESS OF RECOMMENDATION, THE PHYSICIAN PREFER USING PREFACE SHEATH. 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 INTROUDCER."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ABLATION PROCEDURE, THE CELCIUS THERMOCOOL CATHETER DID NOT MOVE SMOOTHLY WITH THE PREFACE SHEATH. THE DOCTOR CONTINUED WITH THE PROCEDURE AND AT THE END OF THE CASE, THE CATHETER WAS STUCK IN THE PREFACE SHEATH. THE DOCTOR THEN PULLED BOTH THE SHEATH AND CATHETER OUT TOGETHER WITH NO CONSEQUENCES TO THE PT. AFTER BOTH SHEATH AND CATHETER WERE REMOVED OUT OF THE PT, THE PHYSICIAN TRIED TO MANIPULATE THE CATHETER AND WHEN PUSHING THE CATHETER, THE TIP OF THE SHEATH SEPARATED.

    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 13082795

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO