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

Catalog Number	INS5010
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This report is 2 of 2 and linked to mfg report number 2648988-2025-00016: a facility reported that the guidewire of the hermetic lumbar catheter, closed tip (ins5010) failed.The drain was flushed and inserted with the wire inside, and when they tried to remove the wire, it got stuck and the wire unraveled.They kept pulling till it came out but it was damaging the drain in some spots.It is unknown if there was patient injury.Additional information received as follows: "there was roughly a 10 min delay for the case.And we just pulled on the wire that was falling apart, and it eventually came out after causing some damage to part of the drain catheter (which we cut off at the end).".
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 fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hermetic lumbar catheter, closed tip (ins5010) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomaly was observed during its manufacturing, packaging, and inspection processes that could be related to the reported condition.Failure analysis - the dispenser box, pouch and ifu correspond to this complaint (mfg report# 2648988-2025-00015).The reported catalog (ins5010) and lot number (7442813) were confirmed based on the identification of the returned dispenser box.However, no catheter and/or guidewire was received for investigation (mfg report# 2648988-2025-00015).Therefore, the reported condition ¿wire stuck and unraveled¿ for investigation (mfg report# 2648988-2025-00015) is considered unconfirmed.Root cause - the root cause is undetermined since the product was returned incompletely.Due to confirmed complaints related to unraveled guidewires, a scar was issued to obtain an in-depth evaluation from the supplier to identify a potential root cause for the reported guidewire breakages and actions that can prevent or reduce the recurrence of the reported condition.The supplier¿s final report did not identify any manufacturing issues.However, the supplier reported that the user should not bend the wire; for example, wrapping the guidewire around the hand or fingers when removing the guidewire since this action could create a force on the distal weld exceeding 2.75 lbs., causing the observed breakage at the distal weld and the guidewire to unravel/stretch.At this moment, no additional information has been received from the customer that would indicate that the guidewire was wrapped around the hand during its retrieval and/or that there were any anatomical feature/anomaly that could difficult the guidewire removal.As a result of events like the one herein reported, a revision to the ifu was implemented to include cautions that advise the user not to bend the guidewire to prevent unraveling of the guidewire.
Event or Problem Description
N/a.

• 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: 22027348
• Report Number: 2648988-2025-00015
• Device Sequence Number: 15714024
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: INS5010
• Device Lot Number: 7442813
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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