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

Catalog Number	INS5010
Medical Device Problem Code	Difficult to Remove (1528)
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 while removing the guide wire, it began to unravel inside the hermetic lumbar catheter (ins5010).There was surgical delay of 90 minutes; however, no patient injury resulted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h11.The hermetic lumbar catheter, closed tip (ins5010) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.In addition, no photos showing the reported condition have been provided; therefore, the complaint is considered unconfirmed., and the definite root cause cannot be determined.Notwithstanding the above, due to confirmed complaints related to unraveled guidewires, a scar was issued to obtain an in-depth evaluation from the manufacturer 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 breakage at the distal weld and the guidewire to unravel/stretch.Additional information was requested from the user to confirm if the guidewire was wrapped around hand/fingers during its retrieval; however, no response has been received.Although no response has been received, the bending of the guidewire (e.G., wrapping the guidewire around the hand or fingers) is the most probable cause of the reported condition.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.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: 21602069
• Report Number: 2648988-2025-00003
• Device Sequence Number: 18457006
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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