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	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter was returned and investigated by the manufacturer.Patient ivus and angiographic data was also forwarded and reviewed by the manufacturer.The investigation concluded that the catheter most likely became engaged on a mal-apposed stent strut which caused the catheter to become difficult to remove.The review of the returned catheter revealed that the catheter met all applicable specifications for crossing profile, therefore this engagement in the strut was not caused by any issue with the manufacture of the catheter.A review of the device history record indicated that the device was manufactured in accordance with manufacturer procedures and met specifications at time of manufacture.No further investigation required.
Event or Problem Description
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.

• 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
• MDR Report Key: 9402423
• Report Number: 3004722468-2019-00004
• Device Sequence Number: 11443370
• Product Code: OGZ
• UDI-Device Identifier: 00857595006333
• UDI-Public: (01)00857595006333(17)191214(10)806141-A
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019
• Report Date (Section F): 11/26/2019

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 Expiration Date: 12/14/2019
• Device Model Number: TVC-C195-42
• Device Lot Number: 806141-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1