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

Catalog Number	INS5010
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
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
A facility reported that during tevar procedure, the guidewire perforated the hermetic lumbar catheter, closed tip (ins5010) on insertion.The doctor felt resistance on insertion of lumbar catheter; it was a challenging insertion with difficulty feeding the catheter with high resistance.Due to the amount of resistance encountered, the doctor withdrew the catheter, and it was then noted that the guide wire had perforated the tip of the catheter.The doctor reinserted another lumbar catheter without issue.The surgery was delayed for 60 minutes due to the problem encountered.There was no patient injury.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The hermetic lumbar catheter, closed tip (ins5010) was returned for evaluation: device history record (dhr) review - dhr review was not possible because the lot number was not reported.However, all tubes, guidewires, and tuohy needles are verified for dimensions at incoming inspection and thus compliant at the moment of use at the manufacturing area.Failure analysis - investigation of the returned product showed that the tuohy needle was not returned for evaluation.However, the returned catheter shows that it is complete, and the guide wire was inserted inside the catheter.It was observed that the distal (to surgeon) side of the guide wire had exited the device through the catheter¿s tip (the tip was perforated by the wire), and it was also observed that the distal end of the catheter (guide wire inside of it) had a ¿u¿ shape resembling a ¿cane¿.This may indicate that the catheter encountered an obstacle during insertion; for example, if the needle is angled incorrectly, it could lead to contact with surrounding tissue.In addition, the guide wire was bent inside the catheter at different places which may reflect an attempt to forcefully push the device when the reported resistance was felt.Most likely the catheter tip was perforated with the guide wire while trying to force the catheter through.Since the tuohy needle was not returned, another 14 g tuohy needle was used to ensure the tube passed through it without excessive resistance.The catheter (with guide wire) passed through the tuohy without resistance, but some resistance was felt at the places where the guide wire had been bent.Root cause - based on the appearance of the catheter/guide wire, the complaint is considered confirmed.However, the most probable cause for the resistance encountered is likely related to the procedure and not related to the product, since no defect (other than, at the field, bent wire and perforated tip) was observed in the catheter or guidewire that would prevent free insertion of the lumbar catheter.Also, no other complaint about the reported condition has been received in a one-year review performed.As a result, no further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
Event or Problem Description
N/a.

• 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: 22549391
• Report Number: 2648988-2025-00026
• Device Sequence Number: 19838979
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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