MAUDE Adverse Event Report: INTEGRA - PRINCETON HERMETIC LUMBAR CATHETER, CLOSED TIP; N/A

Catalog Number	INS5010
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during insertion of the hermetic lumbar catheter, closed tip (ins5010) in an emergency in the operating room, when the catheter was in place, the surgeon observed leak because of a small drop on the surface.They removed the catheter and inserted a similar new one from a different lot, and there was no issue with the second catheter.Increased surgery time was less than 30 minutes with no adverse consequence for the patient.However, there was an infectious risk to patient if the issue was not detected immediately.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hermetic lumbar catheter, closed tip (ins5010) was not returned and no photos of the catheter were provided.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Since the unit has not been returned for evaluation, the leak condition has not been confirmed, and a root cause determination is not possible at this moment.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The hermetic lumbar catheter, closed tip (ins5010) was subsequently returned for evaluation: failure analysis - one (1) catheter was received and the product identification provided with the catheter corresponds to lot 7391570 and catalog ins5010.The catheter was visually inspected, and no defect was observed with the naked eye.Due to the complaint¿s nature (surgeon saw leak because of small drop on the surface), water was passed through the catheter to assess for possible leaks.A leak was observed at a distance of approximately 42.5cm from the tip of the catheter.A small slit/tear was observed in this area.It is unlikely that the catheter had the slit/tear at the moment of implantation because 100% of the catheters are tested for leaks during the manufacturing process.Root cause - based on the evaluation of the returned unit, the complaint is considered confirmed.Some possible root causes could be: a) repositioning of catheter through the touhy needle which may cut the catheter; b) problems encountered while removing the guidewire causing a tear on catheter; c) catheter was pulled.No further action is required at this moment since there are manufacturing controls to detect/prevent the reported condition and thus the most probable cause is related to the implantation process.Product ifu already includes precautions to prevent catheter transections.
Event or Problem Description
N/a.

• Brand Name: HERMETIC LUMBAR CATHETER, CLOSED TIP
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21764834
• Report Number: 2648988-2025-00007
• Device Sequence Number: 12875681
• Product Code: JXG
• UDI-Device Identifier: 10381780071082
• UDI-Public: 10381780071082
• Combination Product (Y/N): N
• PMA/510(K) Number: K972994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: INS5010
• Device Lot Number: 7391570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 06/25/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/22/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown