BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVIS MICROLINE CATHETER INTERFACE

    MDR report key: 118001 · Received September 5, 1997

    Report

    Report Number
    1218950-1997-00043
    Event Type
    Injury
    Date Received
    September 5, 1997
    Date of Event
    August 8, 1997
    Report Date
    August 8, 1997
    Manufacturer
    HEWLETT-PACKARD CO.
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THREE CATHETERS BOUND. THE THIRD CATHETER PUNCTURED THE VESSEL AND WAS WITHDRAWN. IT WAS MENTIONED THAT THE M2402A HAD A FRAYED CABLE, BUT DID NOT CONTRIBUTE. REFERENCE: DISTRIBUTOR REPORT # 1218950-1997-00040 FILED ON ULTRACROSS 30 MHZ CORONARY IMAGING CATHETER. REFERENCE: DISTRIBUTOR REPORT # 2024168-1997-00116 FILED ON ULTRACROSS 30 MHZ CORONARY IMAGING CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVIS MICROLINE CATHETER INTERFACE CATHETER INTERFACE ITX HEWLETT-PACKARD CO. M2402A *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention