MAUDE Adverse Event Report: VOLCANO CORPORATION PIONEER PLUS CATHETER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number PPLUS120

Device Problem No Display/Image (1183)

Patient Problem No Information (3190)

Event Date 11/30/2017

Event Type  malfunction  

Event Description

Doctor advanced ivus catheter.Catheter intermittently displayed images.Physician was not able to image target area of vessel due to blank image screens.Multiple attempts made but unsuccessful.Product did not perform as expected.

• Brand Name: PIONEER PLUS CATHETER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre dr; ste 500; san diego CA 92130
• MDR Report Key: 7134224
• MDR Text Key: 95490475
• Report Number: 7134224
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PPLUS120
• Device Catalogue Number: PPLUS120
• Device Lot Number: 3732441
• 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: 12/13/2017
• Event Location: Other
• Date Report to Manufacturer: 12/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR