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 Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Endograft iliac stent placement.Volcano catheter was used.The wire did not go through it.This is not the first time this has happened with the volcano catheter.This is one of 3 hybrid events regarding , reference # 88901.We searched the internet and found a 'medical device advisory notice' for this item dated 10/13/2018.No known formal notification by the company has been received.According to the udi# (b)(4) is a batch number that is included in the advisory notice.No patient harm.

• 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: 8089818
• Report Number: 8089818
• Device Sequence Number: 16483546
• Product Code: OBJ
• UDI-Device Identifier: 00845225002329
• UDI-Public: (01)00845225002329(17)200731(10)0301480938(90)989609000491
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2018
• Report Date (Section F): 11/02/2018

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: 88901
• Device Catalogue Number: 88901
• Device Lot Number: 0301480938(90)989609000491
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/02/2018