BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    MDR report key: 15923548 · Received December 6, 2022

    Report

    Report Number
    3015551113-2022-00001
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 10, 2022
    Report Date
    March 20, 2023
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OGZ
    UDI-DI
    00857595006234
    PMA / PMN Number
    K183599
    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. SYSTEM LOG FILES AND INTRAVASCULAR IMAGING DATA WERE ALSO PROVIDED TO THE MANUFACTURER AS PART OF THE INVESTIGATION. THE USER-REPORTED ISSUE OF TRANSDUCER DETACHMENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THIS WAS LIKELY A MISTRANSLATION AND THE USER HAD INTENDED TO DESCRIBE THE DISTAL TIP AND A PORTION OF THE IMAGING WINDOW. THE RETURNED CATHETER WAS EVALUATED AND FOUND TO BE IN A CONDITION CONSISTENT WITH THIS INTERPRETATION OF THE USER REPORT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO RELATED NON-CONFORMANCES OR DEVIATIONS WERE NOTED. ADDITIONALLY, BOTH THE IMAGING WINDOW INCOMING TENSILE TEST RESULTS AS WELL AS CATHETER IN-PROCESS TENSILE RESULTS FOR THE ASSOCIATED CATHETER LOT WERE PROVIDED AND REVIEWED. THE TENSILE TESTING RESULTS BOTH AT INCOMING AND IN-PROCESS INSPECTION MET SPECIFICATIONS AND THERE DID NOT APPEAR TO BE ANY MATERIAL OR PROCESS-RELATED ISSUES WITH THE LOT THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. REVIEW OF THE ANGIOGRAPHIC IMAGES CONFIRMED THAT THE DISTAL PORTION OF THE IMAGING WINDOW AND DISTAL TIP REMAINED IN-VIVO DURING CATHETER WITHDRAWAL, BUT COULD NOT BE USED TO CONCLUSIVELY DETERMINE CAUSE. 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. AFTER TREATMENT WITH A DRUG-ELUTING STENT AND DRUG COATED BALLOON (SEQUENT PLEASE) TO THE TARGET LESION, THE NIRS-IVUS CATHETER WAS INSERTED TO EVALUATE STENT PLACEMENT. THE PHYSICIAN REPORTED THAT THE IVUS IMAGE WAS UNCLEAR AND THEN ATTEMPTED TO REMOVE THE NIRS-IVUS CATHETER. WHEN TRYING TO REMOVE THE CATHETER, THE DISTAL TIP OF THE CATHETER SHEATH SEPARATED AND REMAINED IN THE VESSEL. WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SEPARATED PORTION OF THE CATHETER SHEATH, THE GUIDEWIRE ALSO SEPARATED AND REMAINED IN THE VESSEL. THE PHYSICIAN INTERVENED BY DEPLOYING A STENT TO PRESS THE DISTAL TIP OF THE CATHETER SHEATH AND THE GUIDEWIRE AGAINST THE BLOOD VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742601 DUALPRO¿ IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. TVC-C195-42 DPY220901A 00857595006234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown