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

Catalog Number 10185

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 01/17/2014

Event Type  malfunction  

Event Description

When attempting to do a pressure wire procedure, "connect wire" error message kept coming up.A different wire was used without difficulty.

• Brand Name: VERRATA
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore rd.; rancho cordova CA 95670
• MDR Report Key: 3647054
• MDR Text Key: 16453025
• Report Number: 3647054
• 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: 02/21/2014

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: Unknown
• Device Catalogue Number: 10185
• Device Lot Number: SN024320001701045
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR