MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD NEUROMONITOR BOLT KIT; ICP MICROSENSORS

Catalog Number	826632
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2024
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
A facility reported that after implantation, the patient was transferred to the intensive care unit (icu) and the sensor (id 826632) was found fractured.The monitor and cable used were icp express (id 826634) and icp express cable (id 826636).No additional information has been provided after several attempts.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The microsensor (id 826632) was returned for evaluation.Device history record (dhr) - the product code 826632 with lot 6860128 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the catheter received in two sections.No testing possible.The issue of the complaint was confirmed.Root cause analysis - the possible root cause for this issue could be due to ¿improper use or excessive force on product; physical strength of materials unfit for intended use¿.Based the report, it could determine the cause of the issue to be mishandling of the catheter.
Event or Problem Description
N/a.

• Brand Name: NEUROMONITOR BOLT KIT
• Common Device Name: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20214878
• Report Number: 3013886523-2024-00281
• Device Sequence Number: 7328496
• Product Code: GWM
• UDI-Device Identifier: 10381780520429
• UDI-Public: (01)10381780520429(17)271031(10)6860128
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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 Catalogue Number: 826632
• Device Lot Number: 6710471
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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: ICP EXPRESS CABLE (ID 826636); ICP EXPRESS MONITOR (ID 826634)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown