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

Catalog Number	INS5010
Medical Device Problem Codes	Difficult to Insert (1316); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An authorized distributor reported that the tip of the hermetic lumbar catheter, closed tip (ins5010) was cut by the tuohy needle during insertion, and that the issue occurred with 2 different patients.They tried to retrieve the other end (as it got stuck inside) and had to do another trial of insertion.The patient was reported as "symptomatic", but the nature of the symptoms have not been reported.The dysfunction led to increased surgery time of an hour.End user healthcare facility: (b)(6).
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 (ins5010) was not returned because the unit was discarded, and no photos of the reported condition were provided; therefore, failure analysis is not possible.Device history record (dhr) review - lot number information has been provided; therefore, the dhr was reviewed and no anomaly was observed during its manufacturing, packaging, and inspection processes that could be related to the reported condition.Investigation findings: based on complaint details and evaluation of information provided, the tuohy needle does not cut the silicone catheter while being introduced.It is likely that the damage to the catheter is related to catheter positioning technique: the catheter was pulled back/withdrawn through the tuohy needle to reposition or extract the catheter as this type of action will most probably cut the catheter.The product ifu provides the following cautions to prevent such damage: ¿ silicone tears and cuts easily.Use rubber shod forceps when handling silicone catheters.To avoid damage to the catheter, do not withdraw the guidewire without first removing the tuohy needle.Hold the catheter securely at the exit site during needle and guidewire removal to prevent catheter dislodgement.Follow these points to aid needle and guidewire removal and to prevent damaging the catheter: hold the entire length of the catheter straight during needle and guidewire removal do not squeeze the catheter.Excessive compression will increase the difficulty of guidewire removal.Withdraw the guidewire slowly.If the catheter becomes twisted or seizes the guidewire, stop.Allow the catheter to relax and return to its original shape.Slowly start again, being sure to hold the catheter at the exit site.To avoid possible transection of the lumbar catheter, the catheter should never be withdrawn though the tuohy needle.If the catheter needs to be withdrawn, the tuohy needle and catheter (with guidewire if used) must be removed simultaneously.Notwithstanding the above, a root cause determination is not possible since the catheter was not returned.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.

• 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: 23259900
• Report Number: 2648988-2025-00042
• Device Sequence Number: 17369028
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 7378256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2024
• 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