MAUDE Adverse Event Report: VOLCARICA S.R.L. VISIONS PV .035 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	88901
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While using the ivus catheter, when introducing the catheter into the sheath, a malfunction occurred and lost imaging; it went black.Had to then open another package and use a new catheter.There was no patient impact.

• Brand Name: VISIONS PV .035 DIGITAL IVUS CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCARICA S.R.L.; philips; 9965 federal dr.; colorado springs CO 80920
• MDR Report Key: 8248242
• Report Number: 8248242
• Device Sequence Number: 2125392
• Product Code: OBJ
• UDI-Device Identifier: 00845225002329
• UDI-Public: (01)00845225002329(17)201130(10)0301559196(90)989609000491
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/27/2018
• Report Date (Section F): 12/27/2018

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
• Operator of Device: Health Professional
• Device Model Number: 88901
• Device Lot Number: 0301559196
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80
• Date Report Sent to FDA: 12/27/2018