BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    MDR report key: 22677670 · Received July 31, 2025

    Report

    Report Number
    3015551113-2025-00003
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 16, 2025
    Report Date
    November 5, 2025
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OGZ
    UDI-DI
    00857595006234
    PMA / PMN Number
    K241576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED-DEVICE EVALUATION: THE SUBJECT CATHETER (TVC-C195-42; LOT 502031234; (B)(6)) AND A DETACHED DISTAL SHEATH SEGMENT (2.75 IN/70 MM) WERE RECEIVED. THE SEPARATED SEGMENT SHOWED ELONGATION (1,75 IN/44.5 MM) WITH FLATTENING, TEARING, AND NECKING CONSISTENT WITH APPLIED TENSILE FORCE; LOCALIZED KINKING/ROTATIONAL TWISTING WAS ALSO OBSERVED (POTENTIALLY INCURRED DURING DETACHMENT AND/OR SNARE RETRIEVAL). THE IMAGING CORE WAS INTACT BUT EXPOSED BY 1 INCH (25 MM); NO DAMAGE WAS NOTED IN THE REMAINING CATHETER BODY. MANUFACTURING/QUALITY REVIEW: DEVICE HISTORY AND INCOMING MATERIAL RECORDS SHOWED NO NONCONFORMANCES. TENSILE DATA FOR THE SHEATH LOTS EXCEEDED PROCESS SPECIFICATION (+48.7%) AND ISO 10555-1 REQUIREMENTS (+78.4%), INDICATING NO EVIDENCE OF INADEQUATE MATERIAL STRENGTH OR LOW PROCESS CAPABILITY. USE-CONDITIONS AND CONTRIBUTING FACTORS: CASE RECORDS AND PHYSICIAN CORRESPONDENCE INDICATE THE CATHETER WAS INTRODUCED INTO THE RCA POST-STENT DEPLOYMENT; ENTRAPMENT IN THE STENT AND/OR ENTANGLEMENT WITH THE GUIDEWIRE IS THE MOST PLAUSIBLE INITIATING EVENT, NECESSITATING WITHDRAWAL FORCES SUFFICIENT TO SEPARATE THE DISTAL SHEATH. ANGIOGRAPHY AND IVUS IMAGES WERE NOT AVAILABLE DESPITE MULTIPLE REQUESTS, SO THE MECHANISM COULD NOT BE CONFIRMED. SYSTEM LOGS WERE PROVIDED BUT DO NOT PROVIDE ANY FURTHER INFORMATION IN DETERMINING THE CAUSE OF MECHANICAL STRAIN BEING PUT ON THE CATHETER. THE IFU CARRIES RELEVANT WARNINGS REGARDING AVOIDING EXCESSIVE FORCE WHEN RESISTANCE IS ENCOUNTERED AND RISKS OF INTERACTION WITH GUIDEWIRES/STENTS; THESE ARE CONSISTENT WITH THE HYPOTHESIZED MECHANISM. CAPA-000066 WAS INITIATED TO THIS EVENT AND IS ACTIVE; NO DESIGN OR PROCESS DEFICIENCY HAS BEEN IDENTIFIED TO DATE. CONCLUSION: THE EVIDENCE SUPPORTS A PROCEDURE-RELATED MECHANICAL OVERLOAD OF THE DISTAL SHEATH MOST LIKELY AN ENTRAPMENT IN THE DEPLOYED STENT, OR ENTANGLEMENT WITH THE GUIDEWIRE -RATHER THAN A MANUFACTURING OR DESIGN DEFECT. NEITHER CAUSE CAN BE CONCLUSIVELY DETERMINED ABSENT ANGIOGRAPHIC IMAGES. A CORRECTIVE AND PREVENTIVE ACTION (CAPA-000066) WAS INITIATED IN RESPONSE TO THIS ISSUE AND NO PROCESS NOR DESIGN DEFICIENCY HAS BEEN IDENTIFIED. RISK REMAINS ACCEPTABLE WITH CURRENT CONTROLS. CORRECTION: THE INITIAL REPORT (REPORT #(B)(4)) WAS MISNUMBERED. THE CORRECT INTERNAL REPORT NUMBER SHOULD BE (B)(4). ALL SUBSEQUENT FOLLOW-UP REPORTS WILL REFERENCE THE FDA-ASSIGNED NUMBER ASSOCIATED WITH (B)(4) FOR CONSISTENCY.

    Description of Event or Problem · 0

    THE DUALPRO IVUS+NIRS IMAGING CATHETER (MODEL NUMBER: TVC-C195-42) IS A SINGLE-USE CORONARY CATHETER INTENDED FOR USE WITH THE MAKOTO IVUS+NIRS IMAGING SYSTEM. THE PROCEDURE WAS PERFORMED VIA A 6FR RADIAL APPROACH BY TWO PHYSICIANS EXPERIENCED IN NIRS-IVUS IMAGING (PHYSICIAN 1 AND PHYSICIAN 2). THE DUALPRO CATHETER WAS INITIALLY USED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD), WHERE TWO PULLBACKS WERE COMPLETED SUCCESSFULLY AND WITHOUT COMPLICATION. THE PROCEDURE THEN PROCEEDED TO THE RIGHT CORONARY ARTERY (RCA). UPON INITIAL ADVANCEMENT OF THE DUALPRO CATHETER INTO THE PROXIMAL RCA VIA THE GUIDING CATHETER, PHYSICIAN 1 NOTED RESISTANCE. THE CATHETER WAS GENTLY WITHDRAWN WHILE STILL WITHIN THE GUIDING CATHETER, AND THE ENTIRE SYSTEM WAS REMOVED FOR INSPECTION. UPON REMOVAL, PHYSICIAN 1 OBSERVED THAT THE TRANSDUCER AND INTERNAL METALLIC COMPONENTS WERE EXPOSED, AND THE DISTAL PLASTIC SHEATH - TYPICALLY COVERING THE CATHETER'S TIP - WAS MISSING. WITH ANGIOGRAPHIC IMAGING, THE TEAM "SAW TWO MARKERS" IN THE PATIENT'S UPPER ARM, SUGGESTING THE RETAINED SHEATH FRAGMENT'S LOCATION. (NOTE: WHEN INTACT, THE DUALPRO CATHETER HAS A SINGLE RADIOPAQUE PLATINUM-IRIDIUM MARKER LOCATED APPROXIMATELY 5 MM PROXIMAL TO THE DISTAL TIP.) THE TEAM CONVERTED TO A FEMORAL APPROACH AND SUCCESSFULLY RETRIEVED THE DETACHED SHEATH USING A SNARE. THE RECOVERED FRAGMENT MEASURED APPROXIMATELY 7-8 CM IN LENGTH. THE PHYSICIANS WERE CONFIDENT THAT THE ENTIRE FRAGMENT HAD BEEN REMOVED, WITH NO INDICATION OF RESIDUAL MATERIAL. BOTH PHYSICIANS REPORTED NO NOTABLE RESISTANCE OR MECHANICAL STRESS DURING CATHETER USE IN THE LAD. PHYSICIAN 2 HYPOTHESIZED THAT CALCIFICATION AT THE PROXIMAL OR OSTIAL RCA, IN COMBINATION WITH THE ANGLE BETWEEN THE GUIDING CATHETER AND THE ARTERIAL ENTRY POINT, MAY HAVE CONTRIBUTED TO COMPRESSION OR ENTRAPMENT OF THE CATHETER TIP. IT IS SUSPECTED THAT THIS INTERACTION RESULTED IN THE DISTAL SHEATH DETACHING DURING CATHETER WITHDRAWAL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND WAS KEPT OVERNIGHT FOR OBSERVATION. NO ADVERSE CLINICAL OUTCOMES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278781 DUALPRO¿ IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. 502031234 00857595006234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown