BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    MDR report key: 18565454 · Received January 23, 2024

    Report

    Report Number
    3015551113-2024-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    November 30, 2023
    Report Date
    March 1, 2024
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OGZ
    PMA / PMN Number
    K213303
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER AND THE GUIDEWIRE IN USE WERE RECEIVED AND THE INVESTIGATION REVEALED THAT THE ISSUE WAS LIKELY NOT CAUSED BY THE DUALPRO CATHETER IN USE. VISUAL INSPECTION OF THE CATHETER REVEALED A KINK AT THE PROXIMAL END OF THE CATHETER NEAR THE HEAT SHRINK. THERE WAS NO DAMAGE OBSERVED ON THE DISTAL TIP OR IMAGING WINDOW. HOWEVER, THERE WAS SLIGHT DAMAGE TO THE PROXIMAL MONORAIL EXIT, WHICH IS SUSPECTED TO BE CAUSED BY THE GUIDEWIRE IN USE DUE TO THE SEVERE KINKS OBSERVED ON THE GUIDEWIRE. THE CAUSE OF THE KINKING CANNOT BE CONFIRMED AS NO ANGIOGRAMS WERE PROVIDED FOR REVIEW. HOWEVER, IT WAS STATED BY THE DISTRIBUTOR... "THERE WERE TWO NOTICEABLE BENDS ON THE WIRE", INDICATING THAT THE GUIDEWIRE MUST HAVE BEEN KINKED DURING THE PROCEDURE. CATHETERS ARE INSPECTED FOR KINKING AND DAMAGE DURING MANUFACTURING FINAL ACCEPTANCE TEST METHOD; THEREFORE, IT WAS LIKELY THAT THE DAMAGE OBSERVED OCCURRED SUBSEQUENT TO MANUFACTURE. IT IS MOST LIKELY THAT THE USER ATTEMPTED TO TRANSLATE THE CATHETER AND GUIDEWIRE THROUGH A TIGHT LESION, HOWEVER, THIS CANNOT BE CONFIRMED AS ANGIOGRAMS COULD NOT BE PROVIDED FOR REVIEW. THE GUIDEWIRE AND CATHETER WERE INSERTED INTO A VERY TIGHT LESION IN THE CIRCUMFLEX. IT IS POSSIBLE THAT THE ANATOMICAL CONDITIONS OF THE PATIENT POSED DIFFICULTY IN ADVANCING THE GUIDEWIRE AND/OR CATHETER, HOWEVER, AS NO ANGIOGRAMS WERE PROVIDED FOR REVIEW, THIS CANNOT BE CONFIRMED. IT IS UNKNOWN AS TO WHETHER THE DISSECTION OCCURRED DURING THE DELIVERY OF THE GUIDEWIRE OR DURING DELIVERY OF THE CATHETER ON THE GUIDEWIRE. RATHER, THE DISTRIBUTOR STATES THAT IT WAS NOTICED UPON REMOVAL OF BOTH THE GUIDEWIRE AND CATHETER THAT THERE WAS A VESSEL INJURY. IT WAS ALSO STATED THAT THE PATIENT RECOVERED FULLY AND THAT THERE WAS NO PERMANENT DAMAGE. A CAUSAL RELATIONSHIP BETWEEN THE DUALPRO CATHETER AND THE INJURY REPORTED CANNOT BE MADE BASED ON THE INVESTIGATION PERFORMED. PLEASE SEE ATTACHMENT TITLED, "MDR 24-01 REPORT" FOR THE FULL INVESTIGATION REPORT. THE INVESTIGATION OF THIS COMPLAINT WILL BE CLOSED AFTER THE FILLING OF THIS FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. THE DUALPRO CATHETER WAS ADVANCED TO THE LESION AND DID NOT CROSS. THE PHYSICIAN ATTEMPTED TO REMOVE THE DUALPRO CATHETER, BUT MET RESISTANCE AND WAS NOT ABLE TO REMOVE OVER WIRE. THE PHYSICIAN INSTEAD HAD TO PULL THE DUALPRO CATHETER AND WIRE OUT AS A UNIT. WHEN BOTH PIECES OF EQUIPMENT WERE PULLED OUT, THERE WERE TWO NOTICEABLE BENDS ON THE WIRE WITH THE DUALPRO CATHETER ON IT. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO RECROSS LESION WITH MULTIPLE WIRES AFTER REMOVING THE DUALPRO CATHETER. BLOOD FLOW TO LESION HAD BEEN MINIMALLY COMPROMISED (POSSIBLY DUE TO SMALL FLAP OR DISSECTION; HOWEVER UNKNOWN). THE DISSECTION HAPPENED EITHER DURING DUALPRO CROSSING ATTEMPT OR DURING SECOND WIRE CROSSING ATTEMPT. THERE WAS NO ANGIOGRAM PERFORMED IN BETWEEN TO CONFIRM IF THE DISSECTION HAPPENED DURING DUALPRO OR SECOND WIRE. THE PHYSICIAN WAS ABLE TO RE-CROSS LESION, TREAT, REGAIN BLOOD FLOW, STENT ETC. POST ANGIOGRAPHY CONFIRMED SUCCESSFULLY TREATMENT OF THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796381 DUALPRO¿ IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. TVC-C195-42 306261

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention