MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number 22756142

Device Problem Image Display Error/Artifact (1304)

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

Event Date 12/10/2018

Event Type  malfunction  

Event Description

The ultra ice catheter was plugged into the imaging machine and inserted into the left atrium, but the image was very shaky.So, the catheter was unplugged and re plugged in but it had the same issue.There was no change in image so another was used from the same lot number and worked fine.

• Brand Name: ULTRA ICE PLUS
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 47215 lakeview boulevard; fremont CA 94538
• MDR Report Key: 8252651
• MDR Text Key: 133220202
• Report Number: 8252651
• Device Sequence Number: 1
• Product Code: ITX
• 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: 12/20/2018,12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 22756142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1