MAUDE Adverse Event Report: VOLCANO CORPORATION S5I IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	807400001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Volcano ivus system unable to obtain intravascular ultrasound images of coronary arteries, contacted biomed, left voicemail for a callback regarding this issue.
Event or Problem Description
Volcano ivus system unable to obtain intravascular ultrasound images of coronary arteries, contacted biomed, left voicemail for a callback regarding this issue.

• Brand Name: S5I IMAGING SYSTEM
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 7650468
• Report Number: 7650468
• Device Sequence Number: 14056572
• Product Code: IYO
• UDI-Device Identifier: 00845225010218
• UDI-Public: (01)00845225010218
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018
• Report Date (Section F): 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 807400001
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/06/2018