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

Catalog Number	INS5010
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
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 placement of a dse (drainage system extension) catheter under sterile conditions, three punctures were performed.And the epidural space was identified at the l3-l4 level.Cerebrospinal fluid (csf) outflow under pressure was observed, consistent with the patient's known subarachnoid hemorrhage (sah).The mandrel-reinforced catheter was advanced without difficulty, and the introducer needle was removed uneventfully.Upon removal of the mandrel, the mandrel fractured, with the braided wires unraveling and two wires snapping, resulting in damage to the distal portion of the catheter.The mandrel was fully removed; the distal 10-12 cm appeared intact on inspection.As a precaution, the physician cut the catheter at the level of the fissure/break before connecting the catheter to the csf drainage collection system using the provided connector.The catheter was wet but not fully primed with fluid prior to use.The mandrel was not wrapped around the operator's fingers or hand during withdrawal.The incident resulted in a significant increase in procedure time of approximately 1 hour.However, no patient injury was reported.

• 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: 24742094
• Report Number: 2648988-2026-00010
• Device Sequence Number: 18433235
• 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): 06/05/2026

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
• Device Lot Number: 7564266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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