MAUDE Adverse Event Report: VOLCANO CORPORATION EAGLE EYE; CATHETER, ULTRASOUND, INTRAVASCULAR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 02/23/2017

Event Type  malfunction  

Event Description

During heart catheterization, it was decided to use intravascular ultrasound (ivus).The catheter was prepped in normal fashion plugged into the system, advanced over the wire but it would not show on the screen, the screen showed black and would not recognize the catheter.The system was shut down and reconnected, but still wouldn't work.Another was used and it worked fine.Note: these devices do not have lot numbers.

• Brand Name: EAGLE EYE
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore rd.; rancho cordova CA 95670
• MDR Report Key: 6431412
• MDR Text Key: 70782972
• Report Number: 6431412
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR