BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICATH 3.2F, 20 MHZ

    MDR report key: 870658 · Received June 20, 2007

    Report

    Report Number
    6000083-2007-00002
    Event Type
    Malfunction
    Date Received
    June 20, 2007
    Date of Event
    May 21, 2007
    Report Date
    May 23, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    ITX
    PMA / PMN Number
    K970049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN REMOVING THE IMAGING CATHETER FROM THE LESION, THE PHYSICIAN FELT RESISTANCE. THE DISTAL TIP OF THE IMAGING CATHETER SEPARATED OUTSIDE THE PT UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME TYPE DEVICE. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICATH 3.2F, 20 MHZ PERIPHERAL IMAGING CATHETER ITX BOSTON SCIENTIFIC CORP. 37-410 8952698

    Patients

    Seq Age Sex Outcome Treatment
    1 YR V18 GUIDEWIRE| MEDIKIT 7F SHEATH