MAUDE Adverse Event Report: INFRAREDX, INC. DUALPRO¿ IVUS+NIRS IMAGING CATHETER; ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER

Catalog Number	TVC-C195-42
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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prompting an immediate halt to the procedure.The catheter had become lodged in the calcified segment and could not be withdrawn.To dislodge it, the physician attempted to torque the guide catheter, which resulted in a dissection of the rca.During this maneuver, the distal portion of the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, the physician determined that snaring was unlikely to be effective.As a result, the decision was made to stent the fragment in place against the vessel wall.The fragment was successfully secured in this manner.The patient remained hemodynamically stable throughout the event and is recovering well following the procedure.

• Brand Name: DUALPRO¿ IVUS+NIRS IMAGING CATHETER
• Common Device Name: ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): INFRAREDX, INC.; 28 crosby drive, suite 100; bedford MA 01730
• Manufacturer (Section G): INFRAREDX, INC.; 28 crosby drive, suite 100; bedford MA 01730
• Manufacturer Contact: nozomi yagi ; 28 crosby drive, suite 100; bedford, MA 01730
• MDR Report Key: 22553695
• Report Number: 3015551113-2025-00001
• Device Sequence Number: 13151398
• Product Code: OGZ
• UDI-Device Identifier: 00857595006234
• UDI-Public: 00857595006234
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K241576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TVC-C195-42
• Device Lot Number: 504101234
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown