MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED KIT LUMBAR DRAINAGE CEREBROSPINAL FLUID VERSION II; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number NT821707

Device Problems Break (1069); Component Missing (2306); Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problem Pain (1994)

Event Date 02/06/2023

Event Type  malfunction  

Event Description

Anesthesiologist was placing a lumbar drain.It seemed to be an easy insert.The patient complained of sharp feeling.Anesthesiologist tried to advance the catheter but was unable to do so.So, he stopped and removed the catheter.Upon inspection of the catheter, it appeared to be missing the tip portion.The catheter appeared torn.This catheter tip was retained inside the lumbar space.Manufacturer response for kit lumbar drainage cerebrospinal fluid version ii, kit lumbar drainage cerebrospinal fluid version ii (per site reporter).Great to speak with you yesterday! thank you for calling and letting me know about the issues you have experienced with our product.Per our call, you had said that there was more than one instance where the tip of the lumbar catheter broke off.Please complete a form for each incident.If your team can answer for each incident as well, that would be super helpful! ¿ date catheter inserted, ¿ date incident occurred (if known), if not, when discovered, ¿ provider who inserted, ¿ kept catheter after removed from patient? ¿ type of procedure (e.G.Vascular, neuro), ¿ was there difficulty advancing the catheter in the lumbar space? if you are able to put me in touch with the providers who experienced these issues, that would also be really helpful! as with any troubleshooting, i greatly appreciate hearing about one¿s process with the product.As a former neurosurgical intensive care unit registered nurse, i¿ve seen this occur during placement when there is difficulty advancing the catheter.If the lumbar catheter is advanced beyond the tip of the tough needle and gets pulled back, it can cause damage to the tip.Risk of shearing is also increased if a guidewire is used.

• Brand Name: KIT LUMBAR DRAINAGE CEREBROSPINAL FLUID VERSION II
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center blvd; san diego CA 92121
• MDR Report Key: 17142794
• MDR Text Key: 317316019
• Report Number: 17142794
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NT821707
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Female