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

Catalog Number	NL8508330
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 hermetic lumbar catheter, open tip (b)(6) was implanted in a patient and after 2 days, the user noticed that the catheter was torn and there was disintegration of the catheter cover.The catheter was recovered without any problem.No patient injury has been reported.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hermetic lumbar catheter, open tip (nl8508330) was returned for evaluation: device history record (dhr): the dhr was reviewed and no anomalies was observed during its manufacturing, packaging, and inspection process that could be related to the reported condition.Failure analysis: the returned catheter was visually inspected, and it was found that the tip was complete.The catheter has a slanted open tip and 3 holes just as shown in the drawing of "shunt, lumbar peritoneal and lumbar drainage catheter".This catheter has no ¿catheter cover¿ since it is an open-end/open-tip catheter.Therefore, the catheter was not torn and there is no "catheter cover" to disintegrate.Therefore, the reported condition is unconfirmed since the returned device has no defects and per design it has the slanted open tip.Root cause: the complaint is considered unconfirmed since the device is as manufactured.Notwithstanding, it appears that the user thought to have used a closed-end catheter which would have a black plug or cover¿ at the tip (proximal to patient) of catheter.No capa escalation is necessary since the returned device has no defects and per design it has a slanted open tip, the catheter tip was not torn, and it does not have a cover to disintegrate.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: HERMETIC LUMBAR CATHETER, OPEN 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: 22008782
• Report Number: 2648988-2025-00012
• Device Sequence Number: 15427059
• Product Code: JXG
• UDI-Device Identifier: 10381780072393
• UDI-Public: 10381780072393
• 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): 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: NL8508330
• Device Lot Number: 7461052
• 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: 06/11/2025
• 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: 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
• Patient Sex: Unknown