MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. SOUNDSTAR 3D ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 10439011

Device Problems Invalid Sensing (2293); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2017

Event Type  malfunction  

Event Description

Tech reports "bad signal".Per manager: it was a catheter issue.When the catheter was connected, the image was poor.The catheter was removed, and a new catheter was used.The new catheter worked fine.No injury to the patient.

• Brand Name: SOUNDSTAR 3D ULTRASOUND CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 5110 commerce rd.; baldwin park CA 91706
• MDR Report Key: 6503043
• MDR Text Key: 73120350
• Report Number: 6503043
• 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: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 10439011
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2017
• Event Location: Other
• Date Report to Manufacturer: 04/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR