MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. SOUNDSTAR; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 10439011

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

Event Type  malfunction  

Event Description

When the catheter was connected to the cable, there were no contours shown on the carto monitor display.Trouble shooting was unsuccessful.The catheter was removed and a new catheter was used.The new catheter worked properly.No injury to the patient.

• Brand Name: SOUNDSTAR
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 6871653
• MDR Text Key: 86435380
• Report Number: 6871653
• Device Sequence Number: 1
• Product Code: OBJ
• 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: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10439011
• Device Catalogue Number: 10439011
• Device Lot Number: E8070713
• 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: 09/15/2017
• Event Location: Other
• Date Report to Manufacturer: 09/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR