MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD ILUMIEN IMAGING SYSTEM; SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Model Number	900-700-00
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, the imaging system screen went blank and upon removal of the catheter a thrombus was noted.The catheter was in the right coronary artery and after two runs, the screen went blank prior to the contrast being injected.The catheter was removed and thrombus was noted.The procedure was completed with angiography with no patient consequences.After the procedure, the system was tested and it was noticed that it was hard to start the system and the screens were blank.The oct runs were not all captured on the system.Alarms and beeping was heard coming from the system.
Additional Manufacturer Narrative
Per the field service report, the root cause of the blank screen was a failing cmos battery.Once the cmos battery was replaced and the connections were checked, the reported blank screen issue was resolved.The cmos battery failing is due to normal wear and tear.

• Brand Name: ILUMIEN IMAGING SYSTEM
• Common Device Name: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 8797799
• Report Number: 3009600098-2019-00016
• Device Sequence Number: 2484821
• Product Code: NQQ
• UDI-Device Identifier: 00183739000630
• UDI-Public: 00183739000630
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

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: 900-700-00
• Device Catalogue Number: 900-700-00
• Device Lot Number: 3488234
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 11/02/2019
• 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: DRAGONFLY
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR