MAUDE Adverse Event Report: VOLCANO CORPORATION VISION PV.018 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number VISION PV.018

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2015

Event Type  malfunction  

Event Description

During an aortic dissection case, an ivus catheter failed by suddenly displaying only 3/4 of the viewing area.The catheter was removed and a second catheter was used.Roughly 30 minutes later, the second catheter failed showing only 1/2 of the viewing area.That catheter was removed and a third catheter was used to finish the case.No harm to the patient occurred during the failures of both catheters.

• Brand Name: VISION PV.018 DIGITAL IVUS CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 5396056
• MDR Text Key: 36984638
• Report Number: 5396056
• 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: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: VISION PV.018
• Device Catalogue Number: 86700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 90 YR