MAUDE Adverse Event Report: VOLCARICA S.R.L. VERRATA PLUS PRESSURE GUIDE WIRE 185CM; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number 10185P

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/19/2018

Event Type  malfunction  

Event Description

When attempting to do a fractional flow reserve (ffr), we were unable to normalize and the pressure wave would drop downward.Removed from the body and another wire was retrieved.No harm to the patient.

• Brand Name: VERRATA PLUS PRESSURE GUIDE WIRE 185CM
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): VOLCARICA S.R.L.; 3721 valley centre drive, suite 500; san diego CA 92130
• MDR Report Key: 7490135
• MDR Text Key: 107461636
• Report Number: 7490135
• 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: 04/27/2018

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: Unknown
• Device Model Number: 10185P
• 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: 04/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR