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

Catalog Number	INS5010
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
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 the following concerning the hermetic lumbar catheter, closed tip (ins5010): ¿patient with post-traumatic stress intracranial hypertension.Indication for external lumbar derivation for early intracranial hypertension despite sedation.Simple puncture of the dural cul-de-sac by trocar and mandrel.Frank reflex of csf.Pre-moistened guide evd.Ascension without difficulty through the trocar of the evd catheter with its metal guide of approximately 15 cm.When attempting to remove the guide, it rubs abnormally.After obtaining 2-3 cm of withdrawal, the friction is significant which deforms the proximal end of the catheter which becomes serpiginous.Then the guide disintegrates with persistence of the metal core in the kt of evd and then breaks.The catheter is cut at a distance of approximately 15 cm from the skin to allow subcutaneous tunneling.No csf exit.Persistence in the catheter of the distal end of the guide.Removal of this distal end with forceps which restores satisfactory catheter permeability.Immediate action: removal of this distal end with forceps which restores.Good flow through the catheter.Device kept for analysis.¿.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hermetic lumbar catheter (ins5010) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies were observed during manufacture or packaging that could be associated with the complaint incident.Failure analysis - inspection of the returned unit showed that the package included a piece of the catheter, an unraveled guidewire (in 4 pieces), and a piece of the product dispenser box with the product label.From the label, the product lot number was confirmed to be 7353508, as initially reported in the complaint.Guidewire: the guidewire visually was inspected.Guidewire end proximal to hp is bent indicating possible wrapping around fingers or hand.The outer coiled wire was unraveled and was returned in four (4) separate pieces.One (1) of the pieces was inside the piece of catheter returned.As reported by the customer, the entire wire was retrieved; this was confirmed because the tip of the outer guidewire was found inside the package, and it was observed that the inner wire detached from the distal weld.Catheter: a piece of the catheter was returned, it was wrinkled or as described by the customer: it became serpiginous.One (1) of the four (4) pieces of wire was still inside the catheter; the returned catheter portion was straightened, and it measured approximately 46.5 cm long.As described in the complaint, the other portion remained in use because once the wire was removed in its entirety, satisfactory catheter permeability (patency) was restored.Based on the foregoing, the complaint is considered confirmed.Root cause - based on the evaluation of returned unit and the information provided by the client, the most probable root cause for the reported condition is related to the technique used during the guidewire retrieval (wrapping the guidewire around the fingers) which may cause the guidewire to snap/break causing the reported condition.Additionally, due to confirmed complaints related to unraveled guidewires, a scar was issued to obtain an in-depth evaluation from the supplier to identify a potential root cause for the reported guidewire breakages and actions that can prevent or reduce the recurrence of the reported condition.The supplier¿s final report did not identify any manufacturing issues; however, they reported that the user should avoid bending the wire; for example, wrapping the guidewire around the hand or fingers when removing the guidewire.Bending the wire could create a force on the distal weld exceeding 2.75 lbs., causing the observed breakage at the distal weld and subsequent guidewire stretch or unraveling.Trends will be monitored for this and similar issues.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 - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21175739
• Report Number: 2648988-2025-00001
• Device Sequence Number: 18293347
• Product Code: JXG
• UDI-Device Identifier: 10381780071082
• UDI-Public: 10381780071082
• Combination Product (Y/N): N
• PMA/510(K) Number: K970658
• 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): 03/07/2025

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: 7353508
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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