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

Model Number PPLUS120

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2017

Event Type  malfunction  

Event Description

Device stopped working intra procedure.Device was imaged and then stopped imaging.Doctor was unable to get device to work.Per manager: "no harm to the patient.Device was retrieved and vendor called in.

• 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: 6868219
• MDR Text Key: 86296066
• Report Number: 6868219
• 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: 09/13/2017

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
• Device Operator: No Information
• Device Model Number: PPLUS120
• Device Catalogue Number: PPLUS120
• Device Lot Number: G55329
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2017
• Event Location: Other
• Date Report to Manufacturer: 09/13/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2017
• 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: 88 YR