MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER; LICOX BOLTS CATHETERS & KITS

Catalog Number	IP2P
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
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
This report is 3 of 3 for the 1st licox probe implanted, and is linked to mfg report numbers 3006697299-2024-00118 and 3013886523-2024-00243: a facility reported that after implantation involving the "kit containing cc1.P1 and the ip2 introducer (ip2p)", the value remained low at 1-3 mmhg, non-variable with a negative fio2 test.The ct scan showed a good implantation; however, the day after its implementation, the temperature showed improbable values.Additional information received as follows: date of implementation: (b)(6) 2024.Date of explanting: (b)(6) 2024.Has another catheter been inserted? yes, the (b)(6) 2024.How was the patient followed up when the values were inaccurate? empiric management and control by ct scanner and infusion.Decision to replace one on this basis on 16 july.Complicated placement of a small extra-subdural hematoma.2nd implantation of 16 july with hematoma.2nd probe was indeed a licox.It worked well but after delay with low initial values and low reactivity at fio2 increase.The hematoma was secondary to the insertion of the probe.Did the issue(s) with the product arise before a surgery (patient prepared/under anesthesia)? during surgery? when finishing/finalizing the surgery? the procedure for implantation went well.The value during monitoring was aberrant and not interpretable.Did the issue(s) cause any increase of patient care (= ou > 30 minutes)? no.Consequences for patient? attempt to use monitoring for neuro-reanimation.Patient care was not appropriate for several hours.Only if applicable: did the issue(s) result in smoke, fire, and/or burns? no.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The kit containing cc1.P1 and the ip2 introducer ( ip2p) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Device history record (dhr) review - lot number information has been provided; therefore, dhr was reviewed and conformed to the specifications when released to stock.Probable root cause - without actual device to investigate, the exact root cause could not be determined.The probable root cause for the reported complaint could be due to improper handling of the device.As referenced in the licox user's manual lcx02, 60905921 rev c: immediately after inserting the pto2 probe, the pto2 readings are influenced by the evolving microtrauma.This normally applies to the first 20 minutes to 2 hours after insertion.During this phase, the pto2 values do not provide reliable information about tissue oxygenation.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: KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER
• Common Device Name: LICOX BOLTS CATHETERS & KITS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19957455
• Report Number: 3013886523-2024-00242
• Device Sequence Number: 15653713
• 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
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: IP2P
• Device Lot Number: 73552213
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/10/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown