BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICATH ULTRA 3.2F 20 MHZ

    MDR report key: 871906 · Received September 14, 2006

    Report

    Report Number
    6000083-2005-00003
    Event Type
    Malfunction
    Date Received
    September 14, 2006
    Date of Event
    January 11, 2005
    Report Date
    January 20, 2005
    Manufacturer
    SCIMED, A DIVISION OF BOSTON SCIENTIFIC CORP
    Product Code
    DQO
    PMA / PMN Number
    K970049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INVESTIGATION , BLOODSTAINS WERE OBSERVED INSIDE THE DISTAL TIP ASSEMBLY. THE DISTAL TIP ASSEMBLY WAS BROKEN OFF AND MISSING FROM DISTAL TIP END UP TO 1.5MM DISTAL EDGE OF THE RO MARKER. IT IS NOT KNOWN HOW AND WHERE THE DISTAL TIP WAS BROKEN OFF. THE MALE TELESCOPE TUBING WAS DETACHED FROM THE FEMALE TELESCOPE TUBING AT SHAFT SEAL ASSEMBLY. ADDITIONALLY, WATER LEAKED AT SHAFT SEAL ASSEMBLY DURING FLUSHING. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO IMAGING CORE WIND UP IN THE HUB ASSEMBLY. NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC HAS BECOME AWARE OF THE FOLLOWING EVENT AFTER CONDUCTING A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS: IT WAS DETACHED WHEN IT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICATH ULTRA 3.2F 20 MHZ INTRAVASCULAR ULTRASOUND CATHETER DQO SCIMED, A DIVISION OF BOSTON SCIENTIFIC CORP C1020 7067565

    Patients

    Seq Age Sex Outcome Treatment
    1 *