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

Catalog Number	INS5010
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2025
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 the guidewire of the hermetic lumbar catheter, closed tip (ins5010) would not come out once catheter was positioned.Additional information has been requested.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11 device history record (dhr) - the dhr was reviewed, and no anomalies were observed during its manufacturing, packaging, and inspection processes that could be related to the reported condition.Failure analysis: the hermetic lumbar catheter, closed tip (ins5010) was received in one piece.It was measured and it was 80cm.The guidewire was also returned and was in good condition.Other components were returned such as the packaging tray, adapter (flexible luer), blunt needle, strain relief tube, and yellow cap.The guidewire was introduced in the catheter, and the guidewire slid in without any noticeable resistance.The guidewire was introduced all the way to the tip of the catheter; then, the guidewire was retrieved from the catheter without problems or resistance.Therefore, the reported condition could not be reproduced and thus the complaint is considered unconfirmed.Root cause: the reported condition could not be reproduced and therefore a root cause for the reported condition cannot be determined.The catheter and guidewire were in good condition, and the guidewire was inserted in the catheter, and it slid in and out without offering resistance.The product ifu (instructions for use) includes the following warnings that can help prevent catheter damage and/or guidewire resistance: do not use bacitracin solution to flush the catheter and/or guidewire as it may impair the insertion and removal of the guidewire.Use only sterile saline solution to flush the catheter and/or guidewire.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.Avoid bending the guidewire (e.G., wrapping around hand or fingers) since this may contribute to the unraveling of the guidewire.Additionally, no capa escalation is necessary at this moment because the reported condition could not be reproduced on the returned components, and no defect was observed on the returned unit.As an aid to the user, the product ifu already contains warnings (see above) to prevent certain practices that may cause difficulties during guidewire removal.In addition, there is no other complaint to the reported lot that would indicate a failure to comply with the product¿s intended use.No complaint trend signal has been issued for the reported condition.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 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: 22008762
• Report Number: 2648988-2025-00014
• Device Sequence Number: 20792898
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 7472790
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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