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

Lot Number 0243 20069459 024

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 02/11/2016

Event Type  malfunction  

Event Description

During a coronary angiography, the dr felt that the lesion in the lad (left anterior descending) was questionable, so ifr was used to make a definitive diagnosis.Upon the hook up of the pressure wire from volcano an error message displayed on the monitor.It was unplugged then plugged back in, but we received the error message again.So it was replace with a new one (lot #0243 20069459 023).

• 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: 5517469
• MDR Text Key: 40933747
• Report Number: 5517469
• Device Sequence Number: 1
• Product Code: DXO
• 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: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2018
• Device Lot Number: 0243 20069459 024
• 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: 02/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR