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

Model Number 10439011

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Event Description

Eight (8) fr soundstar ultrasound catheter would not initialize at beginning of the procedure.Returned to company no harm to patient/ not entered in patient body.

• 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: 7768116
• MDR Text Key: 116627334
• Report Number: 7768116
• Device Sequence Number: 1
• Product Code: DQO
• 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: 08/02/2018

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
• Device Operator: Other
• Device Model Number: 10439011
• Device Catalogue Number: 10439011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA