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

Catalog Number	INS5010
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that they attempted to get the hermetic lumbar catheter, closed tip (ins5010) in but it stopped working properly and failed due to the obstruction in the catheter.It is unknown if there was injury, surgical delay or increased surgery time.
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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hermetic lumbar catheter, closed tip (ins5010) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomaly was observed during its manufacturing, packaging, and inspection processes that could be related to the reported condition.Failure analysis - the catheter was returned with the guidewire inserted inside of it.It was observed that the guidewire was not completely inserted and that it was bent just before the catheter entry point (likely while trying to push it all the way in).When retrieving the guidewire from catheter some resistance was felt, so we then proceeded to hold the catheter at the tip and it got loose and was easily retrieved from there on.Once the guidewire and catheter were inspected and found in good condition (i.E., catheter not broken and guidewire not unraveled).The guidewire was reinserted into the catheter; however, it could not get it all the way inside; it stopped at about the same distance as when received from the field.This exercise was repeated with a different guidewire to rule out the guidewire as the source of the situation; however, the same result was obtained.To verify if the catheter was occluded, a blunt needle was introduced into the catheter to inject water using a syringe, and water came out from the other side.Therefore, no obstruction was identified at this moment.The guidewire was again introduced in the catheter, and a mark was made at the end of guidewire.This is an approximation because the guidewire is flexible, and it is hard to establish the endpoint.This distance was estimated to be about 4.8 cm from the catheter¿s tip.We then proceeded to cut the tube a bit further down that point to see what was impeding the guidewire to travel after this point, and a silicone rod was observed inside the catheter.The rod does not fill the entire internal diameter of the catheter; hence, water was able to flow through when previously tested.The catheter was split open (lengthwise) with a razor blade and extracted about 3 cm of the silicone rod.The rod was extracted in pieces since it was cut with the blade.The silicone rod is introduced in the catheter during the drilling operation; however, it should have been completely removed once the drilling was completed.Therefore, the reported condition (some kind of obstruction) was confirmed.Root cause - the probable root cause for the reported condition is related to an operator error during the catheter drilling operation based on the finding that a piece of silicone rod was inside the catheter tubing, and about 3 cm of the rod was recovered.This rod originally measures 6 cm and is used during the drilling of the holes found on the catheter¿s tip.However, the operator didn¿t notice the difference in length of the rod and continued with the process.No capa (corrective and preventive action) escalation is required because this is the first instance this failure is reported; also, process documentation already provides instructions to remove the silicone rod and to discard it after completing all holes (drilling operation).An awareness training was provided to the personnel that performs the drilling operation.The awareness training consisted of the discussion of the complaint reported condition, showed photos of the returned unit, discussion of the investigation findings, and stressing the importance of ensuring that the entire length of the rod is extracted once drilling is completed.No complaint trend signal has been issued related to this condition.At present, we consider this complaint to be closed.

• Brand Name: HERMETIC LUMBAR CATHETER, CLOSED TIP
• Common Device Name: N/A
• 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: 23383517
• Report Number: 2648988-2025-00044
• Device Sequence Number: 8752910
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 7536984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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