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

Model Number 10439072

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

Biosense ultrasound catheter reported a sensor error.Catheter was removed and a new catheter was used to complete the case.Multiple similar reports noted in maude for this product.

• Brand Name: SOUNDSTAR
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 15715 arrow hwy.; irwindale CA 91706
• MDR Report Key: 14929769
• MDR Text Key: 295325190
• Report Number: 14929769
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10439072
• Device Catalogue Number: 10439072
• Device Lot Number: G4081171
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other