MAUDE Adverse Event Report: VOLCANO CORPORATION VERRATA; TRANSDUCER, PRESSURE, CATHETER

Catalog Number 10185

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 12/29/2014

Event Type  malfunction  

Event Description

Pressure wire gave us a short condition error message while still in the hoop.

• Brand Name: VERRATA
• Type of Device: TRANSDUCER, PRESSURE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore rd; rancho cordova CA 95670
• MDR Report Key: 4397218
• MDR Text Key: 15908109
• Report Number: 4397218
• Device Sequence Number: 1
• Product Code: DXO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/30/2014

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
• Device Operator: Invalid Data
• Device Catalogue Number: 10185
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR