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

Model Number 10185P

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 07/24/2018

Event Type  malfunction  

Event Description

While opening and checking connection of fractional flow reserve (ffr) wire, it was noticed that the proximal end of the wire was broken inside of the protective connection box.Wire was removed from table and replaced.Wire was not used on the patient, a new wire was opened and the case proceeded with no further complications.No harm to patient.Unfortunately, further identifying information is not available.Wire is not available for return.

• Brand Name: VERRATA PLUS PRESSURE GUIDE WIRE 185CM
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): VOLCARICA S.R.L.; 9965 federal dr.; colorado springs CO 80920
• MDR Report Key: 8018563
• MDR Text Key: 125471430
• Report Number: 8018563
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2018

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: Other
• Device Model Number: 10185P
• Device Lot Number: 73768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA