BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    MDR report key: 8155307 · Received December 12, 2018

    Report

    Report Number
    3004722468-2018-00003
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    December 3, 2018
    Report Date
    December 11, 2018
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OBJ
    UDI-DI
    00857595006333
    PMA / PMN Number
    K163345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PERCUTANEOUS CORONARY INTERVENTION. DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. TARGET LESION; RCA, 90% STENOSIS. DURING THE PROCEDURE, IT IS REPORTED THAT THE IMAGING CATHETER WAS HALTED AFTER ATTEMPTING TO AUTOMATICALLY RETURN TO THE READY POSITION. THE CATHETER WAS THEN REMOVED FROM THE PATIENT AND IT WAS FOUND THAT THE TRANSDUCER PENETRATED THE OUTER SHEATH. THERE WAS DIFFICULTY WITHDRAWING THE CATHETER FROM THE PATIENT. NO INJURY TO PATIENT REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997580 DUALPRO¿ IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OBJ INFRAREDX, INC. TVC-C195-42 806141 00857595006333

    Patients

    Seq Age Sex Outcome Treatment
    1