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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2018
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.Target lesion; rca, 90% stenosis.During the procedure, it is reported that the imaging catheter was halted after attempting to automatically return to the ready position.The catheter was then removed from the patient and it was found that the transducer penetrated the outer sheath.There was difficulty withdrawing the catheter from the patient.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 avenue; burlington MA 01803 4414
• MDR Report Key: 8155307
• Report Number: 3004722468-2018-00003
• Device Sequence Number: 1987567
• Product Code: OBJ
• UDI-Device Identifier: 00857595006333
• UDI-Public: (01)00857595006333(17)181214(10)806141
• 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): 12/11/2018
• Report Date (Section F): 12/11/2018

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: Health Professional
• Device Expiration Date: 12/14/2018
• Device Model Number: TVC-C195-42
• Device Lot Number: 806141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1