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

Model Number	TVC-C195-42
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Diagnostic imaging with a combination near-infrared spectroscopy (nirs) and intravascular ultrasound (ivus) catheter.After treatment with a drug-eluting stent and drug coated balloon (sequent please) to the target lesion, the nirs-ivus catheter was inserted to evaluate stent placement.The physician reported that the ivus image was unclear and then attempted to remove the nirs-ivus catheter.When trying to remove the catheter, the distal tip of the catheter sheath separated and remained in the vessel.When the physician attempted to retrieve the separated portion of the catheter sheath, the guidewire also separated and remained in the vessel.The physician intervened by deploying a stent to press the distal tip of the catheter sheath and the guidewire against the blood vessel.
Additional Manufacturer Narrative
The catheter was returned and investigated by the manufacturer.System log files and intravascular imaging data were also provided to the manufacturer as part of the investigation.The user-reported issue of transducer detachment could not be conclusively determined.However, this was likely a mistranslation and the user had intended to describe the distal tip and a portion of the imaging window.The returned catheter was evaluated and found to be in a condition consistent with this interpretation of the user report.The device history record was reviewed and no related non-conformances or deviations were noted.Additionally, both the imaging window incoming tensile test results as well as catheter in-process tensile results for the associated catheter lot were provided and reviewed.The tensile testing results both at incoming and in-process inspection met specifications and there did not appear to be any material or process-related issues with the lot that could cause or contribute to the reported issue.Review of the angiographic images confirmed that the distal portion of the imaging window and distal tip remained in-vivo during catheter withdrawal, but could not be used to conclusively determine cause.The investigation of this complaint will be closed after the filling of this follow-up report.

• 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
• Manufacturer (Section G): INFRAREDX, INC.; 28 crosby drive, suite 100; bedford MA 01730
• Manufacturer Contact: stephen sum ; 28 crosby drive, suite 100; bedford, MA 01730
• MDR Report Key: 15923548
• Report Number: 3015551113-2022-00001
• Device Sequence Number: 14780221
• Product Code: OGZ
• UDI-Device Identifier: 00857595006234
• UDI-Public: 0857595006234
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 09/20/2025
• Device Model Number: TVC-C195-42
• Device Lot Number: DPY220901A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown