BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO IVUS+NIRS IMAGING CATHETER

    MDR report key: 10770335 · Received November 2, 2020

    Report

    Report Number
    3015551113-2020-00004
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 15, 2020
    Report Date
    January 4, 2021
    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

    PART OF THE CATHETER (PROXIMAL END ONLY) WAS RETURNED FOR INVESTIGATION BY THE MANUFACTURER. THE RETURNED CONDITION OF THE CATHETER PRECLUDED ANY MEASUREMENT OF THE CATHETER CROSSING PROFILE AS THE SHEATH AND TRANSMISSION WINDOW WERE NOT INCLUDED IN THE RETURNED CATHETER PACKAGING. PATIENT ANGIOGRAPHIC DATA (IN AVI FORMAT) WAS ALSO FORWARDED BY THE SITE AND REVIEWED BY THE MANUFACTURER. NO IVUS DATA WAS PROVIDED FOR REVIEW. THE INVESTIGATION CONCLUDED THAT THE CATHETER HAD INDEED BECOME ENTANGLED IN A STENT STRUT(S) WHICH PROTRUDED INTO THE LUMEN. HOWEVER, IT WAS NOT CLEAR HOW THE STENT STRUTS BECAME PROTRUDED INTO THE LUMEN. WHILE THERE IS SUFFICIENT INFORMATION TO STATE THAT THE CAUSE OF THE USER-REPORTED DIFFICULT WITHDRAWAL WAS CAUSED BY PROTRUDED STENT STRUTS, THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHY THE STENT STRUTS HAD PROTRUDED INTO THE LUMEN. THE CAUSE OF THE REPORTED ISSUE DID NOT APPEAR TO BE RELATED TO THE MANUFACTURE OR DESIGN OF THE DEVICE IN USE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURER PROCEDURES AND MET SPECIFICATIONS AT TIME OF MANUFACTURE. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY AND INTRAVASCULAR ULTRASOUND CATHETER. TARGET LESION WAS CALCIFIED LCX LESION. A GUIDEWIRE WAS PLACED IN THE LCX FOR PROTECTION. THE IMAGING CATHETER BECAME STUCK IN THE DEPLOYED STENT AND COULD NOT BE WITHDRAWN. THE PHYSICIAN ATTEMPTED POST-STENT DILATATION USING ANOTHER GUIDEWIRE, BUT THE GUIDEWIRE COULD NOT PASS THROUGH THE GUIDE CATHETER. THE PHYSICIAN THEN CUT THE SHAFT OF THE IMAGING CATHETER AND REMOVED THE IMAGING CORE. THE GUIDEWIRE WAS INSERTED TO ADJUST THE LOCATION OF THE IMAGING CATHETER AND THE CATHETER WAS REMOVED SUCCESSFULLY. NO PATIENT INJURY REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233686 DUALPRO IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. TVC-C195-42 DPY191031A 00857595006241

    Patients

    Seq Age Sex Outcome Treatment
    1