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

Catalog Number	INS5010
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
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
Medwatch (mw5167197) was received with the following information: "tip of the lumbar drain catheter sheared when being introduced and a tip of the catheter was retained in the spine." it is unknown if the tip still remains in the spine; however, additional information has been requested.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Corrected field: h6 (impact codes).A duplicate report was submitted for this complaint event under mfg report number 2648988-2025-00011.Consequently, no follow-up mdr will be submitted for duplicate mfg report number 2648988-2025-00011- see below for the findings of our investigation.See missing information below which was not previously reported under mfg report number 2648988-2025-00006: a physician reported that while attempting to place hermetic lumbar catheter, closed tip (ins5010) for drainage, the catheter sheared while trying to reposition.A piece of the catheter remained in the patient.1.What type of procedure was performed? answer: spinal drain was requested prior to tevar.2.When was the product problem discovered (during inspection, before/during/after a procedure)? answer: during the procedure.3.What actions were implemented when the device broke? (search fragments, removing fragments, radiographic testing¿) if applicable, describe actions.Answer: access needle was inserted into the spinal canal without difficulty.Lumbar drain was inserted without difficulties.However, the tip of catheter curled a bit.When i was trying to reposition the catheter, the catheter was noted to be fractured.No resistance was felt during the procedure and repositioning.I immediately consulted neurosurgery.The procedure was aborted.Ct lumbar spine was performed immediately to locate the fragment.Mri lumbar spine was also performed, but the catheter was not visualized on the mri scan.4.Was the patient under anesthesia when the device broke? answer: moderate sedation.5.Was there a delay in surgery due to product problem? if yes, how long? answer: yes, 3 days.6.Was there any patient adverse consequence because of the delay? if yes, please explain.Answer: no.Patient has some weaknesses in bilateral legs after tevar but doesn't seem to be related to the retained fragment.The patient has been followed by neurosurgery immediately after the incident as well as in outpatient visit.7.Was there any anatomical feature, condition, and/or anomaly that could make difficult the catheter insertion or repositioning? answer: no.8.Was the tuohy needle removed prior to repositioning the catheter? answer: no.9.Did they remove the piece of catheter that remained in the patient? answer: no.10.Patient status/outcome.Initially no symptoms.A new lumbar drain was placed 3 days later, and tevar was performed 4 days later.After answer: tevar, patient experience intermittent bilateral leg weakness.11.Is the product available for return? answer: no.We have submitted the product to risk management in our hospital.Investigation findings: hermetic lumbar catheter (ins5010) was not returned, and no photos of the catheter were provided to evaluate and determine the definite root cause.Lot number information has been provided; therefore, device history record (dhr) was reviewed and no anomaly was observed during its manufacturing, packaging, and inspection processes that could be related to the reported condition.A possible cause for the reported event could be related to manipulating or repositioning the catheter through the tuohy needle during its insertion.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.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 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: 21766108
• Report Number: 2648988-2025-00006
• Device Sequence Number: 18265413
• 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: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: INS5010
• Device Lot Number: 7461044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White