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

Catalog Number	INS5010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2025
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
A facility reported that during the process of removal of hermetic lumbar catheter, closed tip (ins5010), the tip of the drain fractured and was retained inside the patient.An immediate ct lumbar spine showed the tip of the drain adjacent to the spinous process, in the fascial space.The patient was reviewed immediately and was clinically stable and well.The decision was made to remove the remnant tip, and it was removed under local anesthetic and sedation.The patient remains well.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h11.The hermetic lumbar catheter, closed tip (ins5010) was returned for evaluation: failure analysis - a catheter was received for evaluation; however, no product labels were included with the returned unit; therefore, the device lot number remains unknown, and no dhr review is possible.Although the lot number is unknown, each tubing lot used in the manufacturing of ins5010 is tested at incoming inspection and must meet with tensile strength, internal and outer diameter requirements.The returned catheter still had the device¿s flexible luer connector attached to it, and the luer connector was secured with sutures; however, the catheter was tied with an additional thread right around the ¿15¿ mark (15 cm after the black dot).It is unknown the purpose of such suture.There is evidence of what appears to be blood residue on the thread.The catheter was broken just before the last of the perforations (holes) which is perforated at about 0.65 inches from the tip at the proximal (to patient) end.The breakage appears to be torn and not a cut based on the uneven type of tear observed.The other part of the catheter was not returned for evaluation although the complaint information states that it was removed from the patient.Since the hole was partially on the catheter torn end, it was used as reference to determine the catheter overall length.The hole was placed at 0.65 inches (approximately 5/8 inch) and a catheter length of 32.88 inches was obtained.The catheter overall length was displaced by approximately 1.4 inches (from a 31.50 nominal value to 32.88 inches).Therefore, the catheter appears to be stretched.The catheter was most likely stretched during removal when it was pulled to extract it from the spine.As a result, the complaint is considered confirmed.Root cause - the catheter broke near the last perforation (hole) on the proximal (to patient) end of catheter.The catheter was most likely stretched when it was pulled to extract it from the spine.Catheter extraction may encounter difficulties which can increase resistance to catheter withdrawal (e.G., catheter knotting/kinking including entanglement with surrounding tissue, patient anatomical variations, patient position, compression in narrow intervertebral space, etc.).Thus, the most probable cause for the reported condition is that the catheter was pulled/stretched beyond its breaking point, causing it to break into two (2) pieces.No capa escalation is required because the evidence observed on the returned unit device suggests that the device was pulled/stretched beyond its breaking point during catheter extraction.Additionally, no complaint trending signal has been reported for the reported condition.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: 21987097
• Report Number: 2648988-2025-00013
• Device Sequence Number: 19905471
• 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
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 06/30/2025

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
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown