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

Model Number TVC-MC10

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Event 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.

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¿
• Type of Device: 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
• MDR Text Key: 282035277
• Report Number: 3015551113-2021-00001
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00857595006432
• UDI-Public: (01)00857595006432(11)180509
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TVC-MC10
• Device Catalogue Number: TVC-MC10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1