BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    MDR report key: 19733945 · Received July 12, 2024

    Report

    Report Number
    3015551113-2024-00002
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 25, 2024
    Report Date
    October 15, 2024
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OGZ
    UDI-DI
    00857595006197
    PMA / PMN Number
    K183599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS RECEIVED AND THE USER REPORTED ISSUE WAS CONFIRMED. THE CATHETER SHEATH WAS RETURNED IN TWO PIECES, SEPARATED AT THE PROXIMAL BOND. THE COMPLAINT SUMMARY STATED THAT THE "TIP" OF THE CATHETER WAS "STUCK" IN THE PATIENT BUT WAS LATER RECOVERED. IT WAS CONFIRMED THROUGH INVESTIGATION AND IMAGES PROVIDED BY THE DISTRIBUTOR THAT THE PART THAT WAS "STUCK" IS REFERRING TO THE SUB-ASSEMBLY DG2707, ASM, SLEEVE DISTAL TIP, MC10 OF THE CATHETER. THERE WAS A BEND ON THE PEEK MATERIAL (MID SHAFT) APPROXIMATELY 13.875 INCHES FROM THE PULLBACK JOINT. NO OTHER KINKING OR DAMAGE WAS OBSERVED TO THE PEEK MATERIAL. THE CATHETER CORE WAS ABLE TO ROTATE AND TRANSLATE FREELY. HOWEVER, DUE TO DG2707 BEING SEPARATED FROM THE REST OF THE CATHETER, THE TORQUE CABLE (TC) WAS EXPOSED AND COILING OF THE EXPOSED PORTION OF THE TC WAS FOUND APPROXIMATELY 1.5 INCHES DISTAL TO THE DISTAL TIP. THE OUTER DIAMETER OF THE COILED PORTION OF THE TC WAS MEASURED AT 0.76MM, WHEREAS THE REST OF THE TC THAT WAS NOT DAMAGED WAS MEASURED AT 0.72MM. THIS SUGGESTS THAT THE TORQUE CABLE DIAMETER INCREASE RESULTED IN TWISTING OF THE IMAGING WINDOW DURING ATTEMPTS TO TRANSLATE THE CORE. THE COILING OF THE TC IS INDICATIVE OF A STRUGGLE TO TRANSLATE THE CATHETER, CONSISTENT WITH THE USER REPORT AND FINDINGS FROM THE LOG FILES. THE DG2707 WAS SEVERELY BENT AND TWISTED APPROXIMATELY 2.5-3.25 INCHES FROM THE DISTAL TIP. IT IS UNKNOWN WHETHER THIS TWISTING OCCURRED AS A RESULT OF THE ATTEMPTS TO REMOVE THE CATHETER PRIOR TO SEPARATION, OR DUE TO THE PHYSICIAN ATTEMPTS TO REMOVE THE CATHETER SUBSEQUENT TO THE SEPARATION. THE TOTAL LENGTH OF THE DG2707 IN ITS RETURNED CONDITION WAS MEASURED AT APPROXIMATELY 8 INCHES. PER THE DG2707 DRAWING, THE NOMINAL VALUE OF THE LENGTH IS 7.55 INCHES, WITH A MAXIMUM LENGTH OF 7.67 INCHES. THEREFORE, IT IS LIKELY THAT THIS ELONGATION WAS A RESULT OF TENSILE STRESS APPLIED TO THE DG2707 DURING IMPEDED TRANSLATION ATTEMPTS. THERE WAS NECKING OBSERVED AT 3.5 INCHES FROM THE DISTAL TIP, INDICATING THAT ELONGATION HAD OCCURRED. THE DG2707 WAS ALSO BENT FROM 3.5-8 INCHES FROM THE DISTAL TIP. CATHETERS ARE INSPECTED FOR KINKING AND DAMAGE DURING MC10 CATHETER MANUFACTURING FINAL ACCEPTANCE TEST METHOD; THEREFORE, IT WAS LIKELY THAT THE DAMAGE OBSERVED OCCURRED SUBSEQUENT TO MANUFACTURE. IT IS LIKELY THAT SEVERELY TORTUOUS ANATOMICAL CONDITIONS CONTRIBUTED TO THE DIFFICULTY TO REMOVE THE CATHETER. THE CAUSE OF THE SEPARATION AT THE PROXIMAL BOND WAS MOST LIKELY CAUSED DUE TO THE REPEATED ATTEMPTS TO TRANSLATE THE CATHETER, COMBINED WITH THE TENSILE STRESS APPLIED DURING THE ATTEMPTS TO PULL THE CATHETER OUT OF THE VESSEL. ANGIOGRAMS WERE PROVIDED AS AVI FILES AND CONFIRMED THAT THERE WAS 100% OCCLUSION IN THE MID RCA, CONSISTENT WITH THE LOCATION OF WHERE THE DISTRIBUTOR INDICATED THE ISSUE OCCURRED. THE IMAGING WINDOW IS NOT RADIO-OPAQUE AND THEREFORE REVIEW OF ANGIOGRAPHIC DATA CANNOT DIRECTLY OBSERVE THE SEPARATION OR TWISTING OF THE IMAGING WINDOW. ALSO, ANGIOGRAPHY WOULD NOT HAVE RESOLUTION TO REVEAL TWISTING OF THE CATHETER. AS PREVIOUSLY DOCUMENTED, THERE WAS NO PATIENT INJURY REPORTED AND NO PATIENT TREATMENT REQUIRED AS A RESULT OF THE DEVICE MALFUNCTION. 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. FOLLOWING THE NIRS-IVUS SCAN, THE PHYSICIAN AND TECHNICIAN PROCEEDED TO REMOVE THE CATHETER. WHILE DOING SO, THE CATHETER BECAME STUCK IN THE LESION. INITIALLY, THE PHYSICIAN BELIEVED THEY COULD READILY FREE THE CATHETER. HOWEVER, WHILE ATTEMPTING TO REMOVE THE CATHETER, A PORTION OF THE SHEATH SEPARATED AND REMAINED LODGED IN THE VESSEL. AFTER ONE HOUR, THEY WERE ABLE TO SUCCESSFULLY REMOVE THE SEPARATED PORTION OF THE SHEATH. NO PATIENT INJURY REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833804 DUALPRO¿ IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. TVC-C195-42 404051197 00857595006197

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown