MAUDE Adverse Event Report: INFRAREDX, INC. MAKOTO INTRAVASCULAR IMAGING SYSTEM¿; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	TVC-MC10
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
One of the front wheel casters of the mc10 imaging system was reported to have almost fallen off of the console while it was being moved.No patient involvement was reported.
Additional Manufacturer Narrative
Investigation of the product problem concluded that due to the design of the cart, a caster coming off the console did not present a risk of tipping/mechanical hazard.Moreover, caster screws on carts built since 2020 are subject to application of thread-locking adhesive and a torque specification.The cart involved in this complaint was built in 2016 prior to the use of thread-locking adhesive and a torque specification.In response to this complaint, the tvc-mc10 field service manual was revised to include a caster bolt check at preventative maintenance.In addition, the design fmea was updated to add an additional attribute specification regarding console casters.

• Brand Name: MAKOTO INTRAVASCULAR IMAGING SYSTEM¿
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• 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 ; 7813459651
• MDR Report Key: 12832643
• Report Number: 3015551113-2021-00001
• Device Sequence Number: 4316376
• Product Code: IYO
• UDI-Device Identifier: 00857595006432
• UDI-Public: (01)00857595006432(11)180509
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163345
• 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): 02/25/2022

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 Model Number: TVC-MC10
• Device Catalogue Number: TVC-MC10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown