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

Lot Number 23289739

Device Problem Poor Quality Image (1408)

Patient Problem No Information (3190)

Event Date 04/30/2019

Event Type  malfunction  

Event Description

Catheter was prepped in normal fashion.When plugged in, the image quality was very poor.It was unplugged and plugged back in, but the image was still shaky.A new catheter was used and worked fine (different lot number).

• 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: 8631403
• MDR Text Key: 145765979
• Report Number: 8631403
• 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: 05/03/2019,04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 23289739
• 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: 05/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1