Dualpro™ IVUS+NIRS Imaging Catheter Kit TVC-C195-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00857595006234), received between Jul 17, 2018 and Jul 31, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  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 THE CATHETER WAS GENTLY WITHDRAWN WHILE STILL WITHIN THE GUIDING CATHETER, AND THE ENTIRE SYSTEM WAS REMOVED FOR INSPECTION.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 APPROXIMA

  Patient problems: Foreign Body In Patient

  MAUDE report 22677670 ↗
• MalfunctionJul 21, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  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. PRIOR TO CATHETER INSERTION, THE PHYSICIAN PRE-DILATED A HEAVILY CALCIFIED SEGMENT OF THE RIGHT CORONARY ARTERY (RCA). ALTHOUGH RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, THE CATHETER SUCCESSFULLY CROSSED THE LESION. AN AUTOMATED PULLBACK WAS THEN INITIATED TO PERFORM AN IVUS RUN OF THE RCA. AT THE START OF THE PULLBACK, THE PHYSICIAN NOTED AN ABNORMAL WHIRRING SOUND, PROMPTING AN IMMEDIATE HALT TO THE PROCEDURE. THE CATHETER HAD BECOME LODGED IN THE CALCIFIED SEGMENT AND COULD NOT BE WITHDRAWN. TO DISLODGE IT, THE PHYSICIAN ATTEMPTED TO TORQUE THE GUIDE CATHETER, WHICH RESULTED IN A DISSECTION OF THE RCA. DURING THIS MANEUVER, THE DISTAL PORTION OF THE DUALPRO CATHETER SHEATH DETACHED AND REMAINED WITHIN THE VESSEL. UPON REMOVAL OF THE REMAINING SYSTEM COMPONENTS, APPROXIMATELY 6-8 MM OF THE CATHETER SHEATH WAS FOUND TO BE RETAINED IN THE ARTERY. THE PHYSICIAN ATTEMPTED RETRIEVAL BY WITHDRAWING THE GUIDE CATHETER, IVUS CATHETER, AND GUIDEWIRE AS A UNIT, BUT THE EFFORT WAS UNSUCCESSFUL. DUE TO THE FRAGMENT'S LOCATION, TH

  Patient problems: Foreign Body In Patient

  MAUDE report 22553695 ↗
• MalfunctionDec 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  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.

  Patient problems: Insufficient Information

  MAUDE report 15923548 ↗
• MalfunctionDec 3, 2019Difficult to Remove

  DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. IT IS REPORTED THAT THERE WAS SOME DIFFICULTY WITHDRAWING THE IMAGING CATHETER FROM THE CORONARY VESSEL AFTER A STENT (SYNERGY, BOSTON SCIENTIFIC) WAS DEPLOYED AND IVUS EVALUATION WAS PERFORMED. IT IS REPORTED THAT THE IMAGING CATHETER WAS STUCK AROUND THE PROXIMAL END OF THE DEPLOYED STENT. THE IMAGING CATHETER WAS THEREFORE REMOVED USING A BALLOON CATHETER (RYUREI, TERMO) WHICH WAS INSERTED OVER THE GUIDEWIRE (SION BLUE, ASAHI). NO INJURY TO PATIENT REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9402423 ↗
• MalfunctionDec 12, 2018Difficult to Remove

  PERCUTANEOUS CORONARY INTERVENTION. DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. TARGET LESION; RCA, 90% STENOSIS. DURING THE PROCEDURE, IT IS REPORTED THAT THE IMAGING CATHETER WAS HALTED AFTER ATTEMPTING TO AUTOMATICALLY RETURN TO THE READY POSITION. THE CATHETER WAS THEN REMOVED FROM THE PATIENT AND IT WAS FOUND THAT THE TRANSDUCER PENETRATED THE OUTER SHEATH. THERE WAS DIFFICULTY WITHDRAWING THE CATHETER FROM THE PATIENT. NO INJURY TO PATIENT REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155307 ↗
• InjuryAug 29, 2018Image Display Error/Artifact; Component Missing

  PERCUTANEOUS CORONARY INTERVENTION. DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. A FIRST IMAGING CATHETER WAS USED TO SCAN A CORONARY ARTERY. A 90 DEGREE-SIZE WEDGE OF THE TRANSVERSE IVUS IMAGE WAS OBSERVED TO BE MISSING DURING THE SCAN. A SECOND CATHETER WAS TRIED AND A MISSING WEDGE OF THE TRANSVERSE IVUS IMAGE WAS AGAIN OBSERVED DURING THE SCAN. A DIFFERENT BRAND OF IVUS IMAGING CATHETER WAS THEN USED TO SCAN THE VESSEL. A DISSECTION OF THE VESSEL WAS OBSERVED DURING SCANNING AND A STENT WAS DEPLOYED TO TREAT IT. WHILE THE NIRS-IVUS CATHETER WAS NOT DEEMED TO BE THE DIRECT CAUSE OF PATIENT HARM, FAILURE OF THE IVUS IMAGING WITH THE NIRS-IVUS CATHETER COMPLICATED THE PROCEDURE AND MAY HAVE CONTRIBUTED TO USER ERROR.

  Patient problems: Vascular Dissection

  MAUDE report 7826579 ↗
• MalfunctionJul 17, 2018Retraction Problem; Malposition of Device

  PERCUTANEOUS CORONARY INTERVENTION. DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. AFTER PERFORMING A 5TH SCAN WITH THE IMAGING CATHETER, IT WAS REPORTED THAT IT WAS DIFFICULT TO WITHDRAW THE CATHETER FROM THE VESSEL. SEVERAL APPROACHES WERE TAKEN TO REMOVE THE CATHETER, INCLUDING 1-PUSHING AND PULLING THE CATHETER, 2- INSERTING A BALLOON OR MICRO CATHETER ADJACENT TO THE IMAGING CATHETER, 3- TRANSLATING THE IMAGING CORE PROXIMALLY (DURING LIVE IVUS IMAGING), AND 4- CUTTING THE SHEATH TO REMOVE THE IMAGING CORE AND INSERTING A 0.018" GUIDEWIRE. THE LATTER APPROACH WAS ULTIMATELY SUCCESSFUL IN REMOVING THE IMAGING CATHETER FROM THE VESSEL. NOTE THAT IVUS IMAGING WAS LOST AND THE IMAGING CORE WAS NEARLY DETACHED IN THE COURSE OF ATTEMPTING TO WITHDRAW THE CATHETER. A REVIEW OF THE IVUS DATA INDICATES THAT A STENT WAS DEPLOYED IN THE MID/DISTAL VESSEL AND ANOTHER OVERLAPPING STENT WAS DEPLOYED IN THE PROXIMAL VESSEL DURING THE PROCEDURE PRIOR TO THE CATHETER BECOMING STUCK. IVUS IMAGES OF THE SECOND STENT SUGGEST THAT THE STENT WAS MAL-APPOSED TO THE VESSEL WALL. THIS MAL-APPOSITION MAY HAVE CAUSED THE IMAGING CATH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7696102 ↗