MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD C8I ¿ OCT INTEGRATED SYSTEM; OPTISI

Model Number	C408652
Medical Device Problem Codes	Signal Artifact/Noise (1036); Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: the device was not returned for analysis, limiting the investigation to the review of the device history record and the field service report.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 when the sacrificial joint was replaced no further issues were observed.The investigation concluded that based on the information received, the cause of the reported issue was the faulty sacrificial joint.
Event or Problem Description
A dragonfly optis catheter was advanced to the lesion, but when in live view, the vibration from the device was significant.A "pinch test" was performed which showed artifacts.When a pullback was performed, the optis integrated system failed to acquire an image.After two attempts, a second dragonfly optis catheter was prepared.After a pullback was performed with this device, the system was not able to acquire an image either.The procedure was rescheduled and completed on (b)(6) 2018 with no issues.

• Brand Name: C8I ¿ OCT INTEGRATED SYSTEM
• Common Device Name: OPTISI
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 8042682
• Report Number: 3009600098-2018-00017
• Device Sequence Number: 1435171
• Product Code: DQO
• UDI-Device Identifier: 00183739000937
• UDI-Public: 00183739000937
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 11/06/2018

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: 5137572
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/06/2018
• 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