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

Model Number 10439011

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

During electrophysiology (ep) case, the ultrasound device had a sensor error.Device was removed and replaced with same type of device with no further issues.

• Brand Name: SOUNDSTAR
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 15715 arrow hwy; irwindale CA 91706
• MDR Report Key: 10902613
• MDR Text Key: 218192859
• Report Number: 10902613
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/05/2020,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2020
• Date Report to Manufacturer: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA