BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 795007 · Received December 6, 2006

    Report

    Report Number
    3004742046-2006-00509
    Event Type
    Malfunction
    Date Received
    December 6, 2006
    Report Date
    November 8, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NFA
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, PRODUCT PERFORMANCE GROUP ATTEMPTED TO OBTAIN COMPLETE EVENT INFORMATION, INCLUDING PATIENT INFORMATION AND PATIENT STATUS FROM THE HOSPITAL, FIELD CONTACT OR DISTRIBUTOR. THE SECOND RX ACCUNET PART NUMBER 1011649-55, LOT NUMBER 6060851 INDICATED IN B5 AND IN D11, AND IS BEING REPORTED UNDER THE SAME MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DETACHMENT FROM SOURCE. TIME OF MALFUNCTION: DURING PREP. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING PREP WHEN THE TECHNICIAN WAS LOADING THE DELIVERY SHEALTH, THE LIGHT BLUE PEEL AWAY SHEATH WOULD BUNCH UP. IT WAS FOUND THAT THE "TUEY" WAS CLOSED. THE TECHNICIAN DID THIS WITH 2 DIFFERENT FILTER BASKETS DURING THE SAME PROCEDURE. THE PHYSICIAN LOADED A THIRD FILTER BASKET WITHOUT INCIDENT. THE ACCOUNT MANAGER SPOKE WITH THE TECHNICIAN AND DID AN IN-SERVICE AND REVIEW OF THE CORRECT LOADING PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE RETURNED FILTER BASKET DEVICES WERE EVALUATED AND IT WAS FOUND THAT ONE FILTER BASKET TIP BALL WAS DETACHED. THE SECOND FILTER BASKET EVALUATION REVEALED THE SHAPING RIBBON WAS DETACHED FROM THE BALL TIP. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TX ACCUNET EMBOLIC PROTECTION SYSTEM NFA NFA GUIDANT ENDOVASCULAR SOLUTIONS NA 6060851

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN OTHER RX ACCUNET