BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO IVUS+NIRS IMAGING CATHETER

    MDR report key: 10024268 · Received May 5, 2020

    Report

    Report Number
    3015551113-2020-00001
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 20, 2020
    Report Date
    May 5, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER AND SYSTEM CONTROLLER WERE RETURNED AND INVESTIGATED BY THE MANUFACTURER. SYSTEM LOG FILES, INTRAVASCULAR IMAGING DATA, AND ANGIOGRAPHIC IMAGES WERE ALSO PROVIDED TO THE MANUFACTURER AS PART OF THE INVESTIGATION. THE INVESTIGATION CONCLUDED THAT UNDER CLINICALLY-RELEVANT CIRCUMSTANCES IT WAS NOT POSSIBLE TO INDUCE A SHEATH PUNCTURE IN ANY TEST CATHETER. IT WAS POSSIBLE TO INDUCE A SHEATH PUNCTURE ONLY WITH EXTREME MANIPULATION THAT WAS NOT REPRESENTATIVE OF CLINICAL USE. THE CONTROLLER DID NOT EXHIBIT ANY FAILURE OR NON-CONFORMANCE WHICH WOULD HAVE CONTRIBUTED TO THE ABILITY OF THE CONTROLLER TO INDUCE A SHEATH PUNCTURE. THE INVESTIGATION OF THIS COMPLAINT WILL BE CLOSED AFTER THE FILLING OF THIS FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    (B)(4). DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. TARGET VESSEL WAS LMT. TARGET LESION WAS REPORTED 75% STENOSED AND ARTERY TORTUOUS. WHILE THE PHYSICIAN WAS RE-ADVANCING THE IMAGING CORE TO OBSERVE THE LESION, THE IMAGING CORE AUTOMATICALLY STOPPED MOVING. THE ANGIOGRAPHIC IMAGES APPEARED TO SHOW THAT THE IMAGING CORE WAS LOCATED IN THE DIRECTION OF WHAT APPEARED TO BE THE RAMUS ARTERY. HOWEVER, THE PATIENT DID NOT HAVE A RAMUS ARTERY, SO THE PHYSICIAN SUSPECTED A CORONARY ARTERY PERFORATION. THE PHYSICIAN WITHDREW THE CATHETER FROM THE PATIENT, PERFORMED ANGIOGRAPHIC IMAGING AND CONFIRMED THAT THERE WAS NO CORONARY ARTERY PERFORATION. AFTER REMOVAL OF THE CATHETER FROM THE PATIENT, IT WAS FOUND THAT THE IMAGING CORE HAD BREACHED THE SHEATH. IT IS SUSPECTED THAT THE IMAGING CORE ENTERED THE LCX AS THERE WAS NO ARTERY PERFORATION NOTED. A NEW IMAGING CATHETER WAS USED AND THE CASE COMPLETED. NO PATIENT INJURY REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486990 DUALPRO IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. TVC-C195-42 DPY190927A 00857595006241

    Patients

    Seq Age Sex Outcome Treatment
    1