MAUDE Adverse Event Report: CHEMO PORT

Device Problem Occlusion Within Device (1423)

Patient Problem Embolus (1830)

Event Date 04/23/2018

Event Type  malfunction  

Event Description

Right subclavian chemo therapy catheter placed in past.Found to be embolized to right atrium.Removed with snare.

• Brand Name: CHEMO PORT
• Type of Device: CHEMO PORT
• MDR Report Key: 7510895
• MDR Text Key: 108273285
• Report Number: MW5077201
• Device Sequence Number: 1
• Product Code: LJT
• 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: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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: 53 YR