MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER; LICOX BOLTS CATHETERS & KITS

Catalog Number	IP2P
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The kit containing cc1.P1 and the ip2 (ip2p) introducer was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the device was not returned with the packaging, and the probe was not returned with the protective sheath.The accessories were returned: probe and compression cap, and the returned product was decontaminated, the device was investigated visually and under the binocular microscope; the catheter of the probes is in its electrolytic solution.The electrodes wires are wavy and the positioning was not correct since the cathode was bent, it tips was more than 10 mm away from the tip, whereas the cathode tip should be at 2±1 mm + 3±1 mm from the probe¿s tip.The verification before using the monitor test passed; however, the functional probe test done in the air, failed; the obtained result is out of the range.As the test failed, the sections c and d were not performed.Root cause - the complaint is confirmed via the evaluation.The root cause of the observations is due to human misuse and/or atypical forces that were applied to the licox system causing lead kink marks and electrode twisting.Moreover, it is mentioned in section warnings of the ifu (bl675002 rev a) that; ¿the use of excessive force on any component of the licox system may cause damage and malfunction.All mechanical features of the licox system can be operated without the use of excessive force¿.Atypical forces were used on the device, which resulted in its current state.No corrective action is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
A facility reported that the "kit containing cc1.P1 and the ip2 introducer (ip2p)" was inserted on thursday, april 10th and on april 12th, pbo2 started to read 500 and continued to do so.Temperature continues to read at normal patient baseline values, and a ct scan was completed to verify probe placement.A new machine and cable has been switched out and continued to read pbo2 at 500.Additional information received as follows: 1.What type of procedure was performed? answer: insertion of licox, after a few days the pbt02 began reading falsely high numbers.The average number was 500.2.Was there a delay in surgery due to product problem? if yes, how long was the surgical delay in minutes? answer: no 3.Has the probe already removed? if yes, please provide date of explantation.Answer: no 4.How was the patient monitored when the values were inaccurate? answer: a cerelink catheter was also insitu.We continued to monitor clinically and ignored the pbt02 values 5.Please confirm if there was another probe inserted? answer: yes a cerelink catheter was insitu 6.Patient outcome/status: answer: remains admitted in icu.

• Brand Name: KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER
• Common Device Name: LICOX BOLTS CATHETERS & KITS
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23325103
• Report Number: 3013886523-2025-00284
• Device Sequence Number: 18795647
• Product Code: GWM
• UDI-Device Identifier: 10381780250333
• UDI-Public: 10381780250333
• Combination Product (Y/N): N
• PMA/510(K) Number: K040235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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 Expiration Date: 05/31/2025
• Device Catalogue Number: IP2P
• Device Lot Number: 7408342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CERELINK CATHETER.
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 73 KG