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

Model Number 910121

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/14/2020

Event Type  malfunction  

Event Description

During lumbar catheter insertion, the catheter kinked and could not be advanced.A section of the catheter lumbar catheter section broke while trying to remove kinked catheter leaving a retained fragment in spinal canal.Physician determine that the retained section of catheter would not pose a patient safety issue and a new catheter was successfully inserted and placed.

• Brand Name: LUMBAR CATHETER ACCESSORY KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus road; princeton NJ 08540
• MDR Report Key: 10000359
• MDR Text Key: 189003052
• Report Number: 10000359
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 910121
• Device Catalogue Number: 910121
• Device Lot Number: 0215674
• 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: 04/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Weight: 119