MAUDE Adverse Event Report: INFRAREDX, INC. TVC INSIGHT CATHETER; ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number	TVC-C195-20
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Percutaneous coronary intervention of the left anterior descending (lad) coronary artery.Diagnostic imaging with a combination near-infrared spectroscopy (nirs) and intravascular ultrasound (ivus) catheter.Thrombus was formed in the lad while attempting to cross a lesion with the nirs-ivus catheter.The catheter was removed and the thrombus was aspirated with an aspiration catheter to restore blood flow.No further attempt was made to use the nirs-ivus catheter following aspiration.Operator reported feeling resistance while attempting to cross the lesion through the tortuous vessel, possibly harming the intima and causing a thrombus.

• Brand Name: TVC INSIGHT 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: 7023059
• Report Number: 3004722468-2017-00003
• Device Sequence Number: 2037075
• Product Code: OGZ
• UDI-Device Identifier: 00857595006203
• UDI-Public: (01)00857595006203(17)180821(10)G37614
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/10/2017
• Report Date (Section F): 10/17/2017

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: Physician
• Device Expiration Date: 08/21/2018
• Device Model Number: TVC-C195-20
• Device Lot Number: G37614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2017
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention