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

Model Number	10438577
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Unable to obtain desired views when inserted into the patient's body, error message read on carto workstation.No harm to patient.New device utilized without error.

• Brand Name: SOUNDSTAR
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd; baldwin park CA 91706
• MDR Report Key: 12631294
• Report Number: 12631294
• Device Sequence Number: 1205429
• Product Code: OBJ
• UDI-Device Identifier: 10846835008838
• UDI-Public: (01)10846835008838(17)220319
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/08/2021
• Report Date (Section F): 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10438577
• Device Catalogue Number: 10438577
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 129
• Date Report Sent to FDA: 10/08/2021