MAUDE Adverse Event Report: CODMAN & SHURTLETT CODMAN NEURO; 4.0X23MM STENT

Model Number ENF402300

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/31/2018

Event Type  Injury  

Event Description

Stent was partially out of the delivery system.This item did not reach the pt.

• Brand Name: CODMAN NEURO
• Type of Device: 4.0X23MM STENT
• Manufacturer (Section D): CODMAN & SHURTLETT ; raynham MA
• MDR Report Key: 7317032
• MDR Text Key: 101775933
• Report Number: MW5075707
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: ENF402300
• Device Lot Number: 108825232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2018
• 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 Outcome(s): Required Intervention