BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-TIP CATHETER PRESSURE TRANSDUCER

    MDR report key: 213295 · Received March 9, 1999

    Report

    Report Number
    1625382-1999-00002
    Event Type
    Malfunction
    Date Received
    March 9, 1999
    Date of Event
    November 27, 1998
    Report Date
    February 24, 1999
    Manufacturer
    MILLAR INSTRUMENTS INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 11/27/98, DURING THE ROUTINE CARDIAC CATHETERIZATION OF PT, THE DISTAL TIP OF MIKRO-TIP CATHETER TRANSDUCER BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-TIP CATHETER PRESSURE TRANSDUCER ANGIOGRAPHIC CATHETER WITH SINGLE PRESSURE SENSOR DQO MILLAR INSTRUMENTS INC. SPC-474A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR