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

Model Number	10185P
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Ifr wire initially tracing but then tracing disappeared and didn't come back.Wire was disconnected and reconnected with no improvement.New wire used with no difficulty.

• Brand Name: VERRATA PLUS PRESSURE GUIDE WIRE 185CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCARICA S.R.L.; 9965 federal dr.; colorado springs CO 80920
• MDR Report Key: 9653087
• Report Number: 9653087
• Device Sequence Number: 16749762
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/19/2019
• Report Date (Section F): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10185P
• Device Catalogue Number: 10185P
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 59
• Date Report Sent to FDA: 12/19/2019