MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD C8I ¿ OCT INTEGRATED SYSTEM; SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Model Number	C408652
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
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
The procedure was postponed due to a connection issue that occurred after a catheter was disconnected without using the eject button.Another catheter was used but the issue persisted.The issue was isolated to the system.There were no adverse patient consequences.
Additional Manufacturer Narrative
The device was not returned for analysis, limiting the investigation to the review of the device history record.The device met specifications prior to leaving abbott manufacturing facilities as supported by a review of the device history record.The field service report was provided and review noted that the system passed functional tests with no issues observed.The cause for the reported connection issue and subsequent delay remain unknown.

• Brand Name: C8I ¿ OCT INTEGRATED 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: 8546870
• Report Number: 3009600098-2019-00010
• Device Sequence Number: 14061179
• Product Code: NQQ
• UDI-Device Identifier: 00183739000937
• UDI-Public: 00183739000937
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141769
• 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): 06/20/2019

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: C408652
• Device Lot Number: 5591593
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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