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

Catalog Number	NL8508330
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch #mw5170290 was received and report as follows: "during placement of lumbar drain catheter, the catheter broke inside the patient lower back.The attending surgeon verified and confirmed that the catheter was retained.About 4 inches of the catheter was retained.".
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.
Additional Manufacturer Narrative
Updated field: d4, d9, g3, g6, h2, h3, h4, h11.The hermetic lumbar catheter (nl8508330) was not returned and no photos were provided; therefore, an evaluation of the device could not be performed.The device history record (dhr) of finished goods lot #7496048 was reviewed and no anomaly was observed during its manufacturing, packaging, and inspection processes that could be related to the reported condition.The unit was not returned for evaluation; hence, a root cause determination is not possible.However, a possible root cause for catheter breakage may be related to the technique used during catheter implantation.If during insertion the catheter is pulled back through the tuohy (e.G., for repositioning purposes), it may be damaged or transected.As per product ifu: ¿to avoid possible transection of the lumbar catheter, the catheter should never be withdrawn through the tuohy needle.If the catheter needs to be withdrawn, the touhy needle and catheter (with guide wire if used) must be removed simultaneously.If additional relevant information becomes available in the future,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.
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: 22235209
• Report Number: 2648988-2025-00021
• Device Sequence Number: 8026497
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NL8508330
• Device Lot Number: 7496048
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White