BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCIMED BOSTON SCIENTIFIC CORP.

    MDR report key: 147203 · Received December 31, 1997

    Report

    Report Number
    147203
    Event Type
    Malfunction
    Date Received
    December 31, 1997
    Date of Event
    September 17, 1997
    Report Date
    September 22, 1997
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CATHETER TESTED PRIOR TO USE, BUT DURING PROCEDURE WAS FOUND TO BE DEFECTIVE. (WOULD NOT PRODUCE AN IMAGE) SECOND CATHETER TESTED AND ALSO FOUND TO BE DEFECTIVE. SCIMED TECH SUPPORT CALLED; ASKED THAT USER FACILITY TRY ANOTHER CATHETER WITH A DIFFERENT LOT#. THIS WAS DONE AND CATHETER FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCIMED BOSTON SCIENTIFIC CORP. ULTRACROSS 3.2F 30 MHZ CORONARY IMAGING CATHETER IYO BOSTON SCIENTIFIC CORP. REF C2018 6218N-4

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other