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

Catalog Number INS-5010

Device Problem Component Missing (2306)

Patient Problems Cerebrospinal Fluid Leakage (1772); Device Embedded In Tissue or Plaque (3165)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

A (b)(6) year old patient was admitted for a cerebrospinal fluid (csf) leak post back surgery.A closed insertion of a lumbar drain was attempted by neurosurgical physician's assistant (pa) at the bedside.The pa noted the distal tip of the drain was missing when she removed the drain.The neurosurgeon determined the risk of removal was greater than the risk of leaving the tip.The patient was informed.

• Brand Name: HERMETIC LUMBAR CATHETER CLOSED TIP
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA; 5955 pacific center blvd; san diego NJ *
• MDR Report Key: 4758294
• MDR Text Key: 5789685
• Report Number: 4758294
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: INS-5010
• Device Lot Number: 1150391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR