MAUDE Adverse Event Report: VOLCARICA S.R.L. VERRATA; TRANSDUCER, PRESSURE, CATHETER TIP

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/26/2018

Event Type  malfunction  

Event Description

Volcano pressure wire was inserted and normalized.After advancing across the lesion the waveform on the wire then went away.It was unplugged and plugged back in to try to fix the issue but it didn't work.There was still no waveform, so a new one was used and worked fine.The patient was not affected.

• Brand Name: VERRATA
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): VOLCARICA S.R.L.; 2870 kilgore rd; rancho cordova CA 95670
• MDR Report Key: 7288671
• MDR Text Key: 100700306
• Report Number: 7288671
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/26/2018,01/30/2018

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: No Information
• Device Expiration Date: 01/31/2021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO