MAUDE Adverse Event Report: Integra NeuroSciences PR Hermetic Lumbar Catheter, Closed Tip; External CSF Drainage

Catalog Number	INS5010
Medical Device Problem Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11 the hermetic lumbar catheter (ins5010) was not returned, and no photos of the reported condition (catheter sheared) could be evaluated/verified.The device history record (dhr) review was not possible since the product¿s lot number was not reported.Although the lot number is unknown, each tubing lot must comply with incoming requirements including break load force, elongation, and raw material tensile strength.Additionally, the product¿s instructions-for-use (ifu) provides the following cautions: ¿ 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: o hold the entire length of the catheter straight during needle and guidewire removal o do not squeeze the catheter.Excessive compression will increase the difficulty of guidewire removal.O withdraw the guidewire slowly.O 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hold the catheter at the exit site.¿ to avoid possible transection of the lumbar catheter, the catheter should never be withdrawn though the tuohy needle.If the catheter needs to be withdrawn, the tuohy needle and catheter (with guidewire if used) must be removed simultaneously.The complaint could not be confirmed, as the device was not returned for evaluation and no physical evidence was available to substantiate the reported event.Owever, based on the available information, a potential root cause is improper catheter positioning or withdrawal technique.Specifically, catheter damage may occur if the catheter is withdrawn through a tuohy needle during repositioning or removal, allowing the needle bevel to partially or completely shear the catheter.If such damage is not detected during the procedure, it may only become apparent upon final catheter removal.Should additional relevant information become available, this complaint will be reopened and further evaluated as appropriate.Trends related to this and similar issues will continue to be monitored.Based on the information currently available, this complaint is considered closed.

• Brand Name: Hermetic Lumbar Catheter, Closed Tip
• Common Device Name: External CSF Drainage
• Manufacturer (Section D): Integra NeuroSciences PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): Integra NeuroSciences PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 50161278
• Report Number: 2648988-2026-00023
• Device Sequence Number: 16096280
• Product Code: JXG
• UDI-Device Identifier: 10381780071082
• UDI-Public: 10381780071082
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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
• 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: 07/17/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown