MAUDE Adverse Event Report: CAROTID STENT; STENT, CAROTID

Device Problems Break (1069); Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Vascular lab probe was being used to check carotid stent placement, probe cover broke and contaminated stent.Stent was removed from patient, contaminated items removed from field.Area and instruments cleaned with betadine paint.New stent opened and placed.Fda safety report id # (b)(4).

• Brand Name: CAROTID STENT
• Type of Device: STENT, CAROTID
• MDR Report Key: 12711426
• MDR Text Key: 279258825
• Report Number: MW5104996
• Device Sequence Number: 2
• Product Code: NIM
• 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: 10/25/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2021
• 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