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

Model Number 8 FR.

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2016

Event Type  malfunction  

Event Description

The soundstar eco ultrasound catheter produced a sensor error before it was used on patient.New us catheter opened and was used for the procedure without issues.

• Brand Name: SOUNDSTAR ECO
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 3333 diamond canyon rd; diamond bar CA 91765
• MDR Report Key: 5856409
• MDR Text Key: 51491598
• Report Number: 5856409
• 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: Other
• Type of Report: Initial
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: 8 FR.
• Device Catalogue Number: 10439011
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR