MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION HERMETIC LUMBAR CATHETER TIP; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number INS5010

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/24/2021

Event Type  Injury  

Event Description

Lumbar drain placed in prep for tevar (thoracic endovascular aortic repair) procedure.Following procedure, the pa (physician¿s assistant) removed the lumbar drain.This was complicated by fracture of the lumbar drain with the retained portion just below the skin.A ct was completed showing the retained segment.The patient returned to the operating room for removal of the retained drain segment.

• Brand Name: HERMETIC LUMBAR CATHETER TIP
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 11371874
• MDR Text Key: 233261834
• Report Number: 11371874
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: INS5010
• Device Catalogue Number: INS5010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention