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	Vascular Dissection (3160)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• 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 01803 4414
• MDR Report Key: 7826579
• Report Number: 3004722468-2018-00002
• Device Sequence Number: 19126376
• Product Code: OGZ
• UDI-Device Identifier: 00857595006333
• UDI-Public: (01)00857595006333(17)18101(10)804191
• 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
• Report Date (Section B): 08/15/2018
• Report Date (Section F): 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2018
• Device Model Number: TVC-C195-42
• Device Lot Number: 804191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/08/2018
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention