MAUDE Adverse Event Report: ABBOTT VASCULAR ILUMIEN OPTIS SYSTEM; SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Model Number	C408650
Medical Device Problem Codes	Poor Quality Image (1408); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturing ref: 2184149-2020-00241, 2184149-2020-00240.During the procedure, a significant delay occurred.The start up of the system was significantly prolonged and "ffr receiver fault detect" was displayed after startup.The connection between the catheter and the doc failed and it took two to three times to connect successfully.After detection the imaging effect was not good, the brightness and contrast were not high, and the nature of the plaque could not be seen clearly.The procedure was completed with the same system with no adverse patient consequences.The ffr receivers and optical adapter were replaced to resolve the issue.
Additional Manufacturer Narrative
No component was returned for analysis.The device history record was not reviewed as a manufacturing/design issue is not suspected as the device was manufactured in 2017.Therefore, it has exceeded its design service life expectancy of two years.There are no suspected manufacturing/design/ncmr/capa related issues to reference as a root cause could not be determined.There are no prior related complaints against this system and it has not been returned in the past for refurbishment.The root cause of the reported event could not be determined.No corrective action needed as the root cause of the reported issue could not be conclusively determined.

• Brand Name: ILUMIEN OPTIS SYSTEM
• Common Device Name: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• Manufacturer (Section D): ABBOTT VASCULAR; 4 robbins drive; westford MA 01886
• MDR Report Key: 11095630
• Report Number: 3009600098-2020-00029
• Device Sequence Number: 3756291
• Product Code: NQQ
• UDI-Device Identifier: 00183739000678
• UDI-Public: 00183739000678
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K188320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: Health Professional
• Device Model Number: C408650
• Device Catalogue Number: C408650
• Device Lot Number: 5925133
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AO USB RECEIVER; PW USB RECEIVER; AO USB RECEIVER; PW USB RECEIVER
• Outcome Attributed to Adverse Event: Other