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

Model Number 10439236

Device Problems Device Displays Incorrect Message (2591); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Event Description

There was a sensor error reported with the ablation catheter after placement into the patient.The catheter was removed and replaced without incident or harm to the patient.

• Brand Name: SOUNDSTAR
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd; baldwin park CA 91706
• MDR Report Key: 12891706
• MDR Text Key: 281417978
• Report Number: 12891706
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10439236
• Device Catalogue Number: 10439236
• Device Lot Number: 30542629M
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1