MAUDE Adverse Event Report:; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

We were placing a lumbar drain , physician went to see if cerebrospinal fluid (csf) was coming out of the drain and it wasn't so we confirmed placement with fluoro and injected contrast to verify placement internally.Physician was going to adjust placement of drain and while pulling back the drain broke, leaving a piece of the drain within the patients spinal column.

• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• MDR Report Key: 10689443
• MDR Text Key: 211691876
• Report Number: 10689443
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1