MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LUMBAR CATHETER, CLOSED TIP; EXTERNAL CSF DRAINAGE

Catalog Number	INS5010
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that a patient with lumbar drainage after an anterior communicating artery aneurysm experienced accidental disconnection of the hermetic lumbar catheter, closed tip (ins5010) from the collection system, leading to removal of the catheter due to infection risk.Imaging showed ventricular enlargement, and a new lumbar catheter was inserted.Risks included excessive csf loss if unnoticed and infection.The connection between the catheter and the collection system appeared insufficiently secured.Additional information was subsequently received as follows: "the collection system used is the ventrex complete evd system from neuromedex (ref: (b)(4)).However, the malfunction does not occur at the junction between the catheter and the collection system.The malfunction is upstream, entirely on the integra system.In practice, after inserting the drainage catheter, we insert a connector into it that will allow it to connect the flexible catheter to the neuromedex system.The accidental disconnection occurred there in our case.".
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
Corrected field: h6 (impact code) the hermetic lumbar catheter (ins5010) was not returned, and no photos of the reported condition were provided; therefore, failure analysis is not possible.Additionally, the device history record (dhr) review was not possible because the product lot number was not reported.However, as per information provided, the user inserted ¿a connector¿ into the catheter to connect it to the neuromedex evd system (ventrex® complete).It is unknown if the connector used is the one included with the ins5010 or a different one.The complaint was described as accidental (the catheter accidentally disconnected from the collection system); thus, a possible root cause could be related to inadvertently pulling on or stretching the device causing it to disconnect from the connector (probably during patient handling).Additional contributors may be related to the female luer not being inserted properly into catheter and/or not using ligatures to help fix the catheter to the connector.As per product ifu: ¿the silicone elastomer tubing should be carefully secured to the connector with ligatures in such a manner as to avoid cutting of the tubing.¿ albeit 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: 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 ; 6099362319
• MDR Report Key: 23917252
• Report Number: 2648988-2025-00048
• Device Sequence Number: 9194650
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 12/05/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/20/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VENTREX COMPLETE EVD SYSTEM ((B)(4))
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female