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

Model Number 807400001

Device Problem No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2018

Event Type  malfunction  

Event Description

Volcano ivus system unable to obtain intravascular ultrasound images of coronary arteries, contacted biomed, left voicemail for a callback regarding this issue.

Event 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
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 7650468
• MDR Text Key: 112732381
• Report Number: 7650468
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00845225010218
• UDI-Public: (01)00845225010218
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 807400001
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1