BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO IVUS+NIRS IMAGING CATHETER

    MDR report key: 10403563 · Received August 13, 2020

    Report

    Report Number
    3015551113-2020-00003
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 13, 2020
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OGZ
    UDI-DI
    00857595006241
    PMA / PMN Number
    K163345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS RETURNED AND INVESTIGATED BY THE MANUFACTURER. PHOTOGRAPHS OF THE CATHETER, SYSTEM LOG FILES, INTRAVASCULAR IMAGING DATA, AND ANGIOGRAPHIC IMAGES WERE ALSO PROVIDED TO THE MANUFACTURER AS PART OF THE INVESTIGATION. THE CAUSE OF THE IMAGING WINDOW PUNCTURE COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THERE WAS SCRATCHING AND DAMAGE EVIDENT ON THE IMAGING WINDOW WHICH OCCURRED AT A LOCATION CONSISTENT WITH THE PROXIMAL STENT EDGE AS WAS VISIBLE BY IVUS AND ANGIOGRAPHIC IMAGES PROVIDED. IT WAS POSSIBLE THAT THE IMAGING WINDOW WAS WEAKENED DUE TO CONTACT WITH THE PROXIMAL STENT EDGE. THE INVESTIGATION OF THIS COMPLAINT WILL BE CLOSED WITH THE FILLING OF THIS FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. TARGET REGION WAS RCA WITH CTO IN A TORTUOUS VESSEL. TWO AUTOMATIC PULLBACK SCANS WERE PERFORMED NORMALLY WITHOUT ISSUE. WHEN THE PHYSICIAN READVANCED THE IMAGING CORE MANUALLY AFTER THE SECOND PULLBACK, HE NOTICED THAT THE IVUS IMAGE LOOKED UNUSUAL. AFTER REMOVAL OF THE CATHETER FROM THE PATIENT, THE PHYSICIAN CONFIRMED THE IMAGING CORE PUNCTURED THE OUTER SHEATH. NO PATIENT INJURY REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869679 DUALPRO IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. TVC-C195-42 DPY200612A 00857595006241

    Patients

    Seq Age Sex Outcome Treatment
    1