MAUDE Adverse Event Report: BOSTON SCIENTIFIC BALLOON CATHETER; MONORAIL STERLING CATHETER

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 07/08/2016

Event Type  malfunction  

Event Description

Single use disposable instrument error.We were only notified of this error on 02/21/2018.

• Brand Name: BALLOON CATHETER
• Type of Device: MONORAIL STERLING CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 7327179
• MDR Text Key: 102115948
• Report Number: MW5075778
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR