MAUDE Adverse Event Report: VOLCANO CORPORATION EAGLE EYE PLATINUM DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 85900P

Device Problems Device Alarm System (1012); Difficult to Insert (1316); Output Problem (3005)

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

Event Date 06/25/2019

Event Type  malfunction  

Event Description

Volcano intravascular ultrasound (ivus) catheter was difficult to load onto wire for use.Once catheter was inside patient and intravascular ultrasound exam was started, chromo button was utilized for color flow.Promptly after chromo button was touched on, catheter stopped working and ivus screen was giving a message of "no pim" (no patient interface module (pim)).Imaging was adequate.Ivus catheter and sheath were removed.

• Brand Name: EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore rd.; rancho cordova CA 95670
• MDR Report Key: 8743717
• MDR Text Key: 149487131
• Report Number: 8743717
• Device Sequence Number: 1
• Product Code: OBJ
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85900P
• 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: 06/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 117