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

Model Number	TVC-C195-42
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
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 catheter to become stuck in the stented vessel.No injury to patient reported.No treatment of patient required due to malfunction.

• Brand Name: DUALPRO¿ IVUS+NIRS IMAGING CATHETER
• Common Device Name: ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): INFRAREDX, INC.; 34 third ave.; burlington MA 91793 4414
• MDR Report Key: 7696102
• Report Number: 3004722468-2018-00001
• Device Sequence Number: 2542460
• Product Code: OGZ
• UDI-Device Identifier: 00857595006234
• UDI-Public: 00857595006234
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2018
• Report Date (Section F): 07/09/2018

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: Other
• Device Expiration Date: 09/20/2018
• Device Model Number: TVC-C195-42
• Device Lot Number: 803201
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2018
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1