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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAROTID STENT; STENT, CAROTID
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CAROTID STENT; STENT, CAROTID Back to Search Results
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Malfunction
Event or Problem 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).
 
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Brand Name
CAROTID STENT
Common Device Name
STENT, CAROTID
MDR Report Key12711426
Report NumberMW5104996
Device Sequence Number4550120
Product Code NIM
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 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
Operator of Device No Information
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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