MAUDE Adverse Event Report: ABBOTT VASCULAR ILUMIEN OPTIS IMAGING SYSTEM PIU 2.2; SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Model Number	15200-01
Medical Device Problem Codes	Failure to Power Up (1476); 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	12/29/2020
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
During the procedure, a cancellation occurred.The patient was in-patient overnight for a planned angiogram and oct.An error message appeared on the system stating "a serious error has occurred (111).There is a problem communicating with the doc.Click ok to shut down the oct system." the system was restarted and another error message appeared that stated "configuration error (1337).Invalid hardware configuration.Contact your authorized service representative.Doc error." the angiogram was cancelled.There were no adverse patient consequences.
Additional Manufacturer Narrative
One piu was received for evaluation.Product analysis revealed the reported issue could be duplicated.The device history record was not reviewed as a manufacturing/design issue is not suspected as the device was manufactured in 2013.Therefore, it has exceeded its design service life expectancy of two years.Therefore the failure was determined to be normal wear and tear.There are no previous complaints for this issue associated with this serial number and the unit has not been previously returned for refurbishment.Based on the results of the hardware analysis, the root cause of the reported issue was due to the damaged engine cable.

• Brand Name: ILUMIEN OPTIS IMAGING SYSTEM PIU 2.2
• Common Device Name: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• Manufacturer (Section D): ABBOTT VASCULAR; 4 robbins drive; westford MA 01886
• MDR Report Key: 11174624
• Report Number: 3009600098-2021-00002
• Device Sequence Number: 14163391
• Product Code: NQQ
• UDI-Device Identifier: 00183739000678
• UDI-Public: 00183739000678
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123369
• 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,Followup
• Report Date (Section B): 04/28/2021

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: 15200-01
• Device Catalogue Number: C408650
• Device Lot Number: 4419528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 01/22/2021; 04/28/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/17/2021; 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other