BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICATH ULTRA 3.2F 20 MHZ

    MDR report key: 871901 · Received September 14, 2006

    Report

    Report Number
    6000083-2004-00001
    Event Type
    Malfunction
    Date Received
    September 14, 2006
    Date of Event
    November 4, 2004
    Report Date
    November 18, 2004
    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, VISIBLE BLOODSTAIN WERE OBSERVED INSIDE THE DISTAL TIP ASSEMBLY. THE CATHETER WAS REC'D WITH THE DISTAL TIP BROKEN OFF FROM THE "RO' MARKER. THE BROKEN SECTION OF THE TIP WITH THE "RO" MARKER WAS RETURNED, AND WAS 7.0MM LONG. FURTHERMORE, THE GUIDEWIRE EXIT PORT WAS EXAMINED AND WAS FOUND TO BE NORMAL WITH NO DAMAGE. VISUAL EXAMINATION OF THE TIP SECTION WHERE THE SEPARATION OCCURRED INDICATED APPLICATION OF AXIAL FORCE DURING USE OF THE CATHETER. DURING IMAGE CHARACTERIZATION TESTING, GOOD SQUARE IMAGE APEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. 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 FELT RESISTANCE DURING DELIVERY. IT WAS TORE AT DISTAL TO DISTAL MARKER DURING REMOVAL.

    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 6657001

    Patients

    Seq Age Sex Outcome Treatment
    1 *