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

Model Number 10439236

Device Problem Device-Device Incompatibility (2919)

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

Event Date 04/08/2022

Event Type  malfunction  

Event Description

The diagnostic ultrasound catheter was not recognized by the carto system.The catheter was removed and replaced with a new catheter, without harm to the patient.This happened with two different products (different lots).Manufacturer response for diagnostic ultrasound catheter, soundstar eco ultrasound catheter (per site reporter).Escalated to manufacturer in january.Multiple reports filed in medsun for this item.Manufacturer without findings as of yet.

• Brand Name: SOUNDSTAR
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 15715 arrow hwy; irwindale CA 91706
• MDR Report Key: 14205773
• MDR Text Key: 290065476
• Report Number: 14205773
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10439236
• Device Catalogue Number: 10439236
• Device Lot Number: G9232358 AND G9224859
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other