MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ICP SENSOR CATHETER KIT; ICP MICROSENSORS

Catalog Number	826633
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2024
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 a microsensor (id 826633) could not showed the normal readings.This happened after the patient was sent back to ward.The reading was inaccurately positive and sometimes negative, then the increased intracranial pressure (icp) reading become -99mmhg.Therefore, the physician stop monitoring and removed the sensor on (b)(6) 2024.The monitor used was icp express, 220 volt (id 826635) and the cable used was icp express cable (id 826636).
Additional Manufacturer Narrative
The microsensor (id 826633) was returned for evaluation.Device history record (dhr) - the batch record was reviewed for any anomalies or non-conformances related to the finished device, and none were identified, related to this report.Failure analysis - the catheter received with suture tied on.The icp express read 509.The sensor cannot be balanced or adjusted.The catheter failed water pattern testing - off scale.Root cause analysis - unable to confirm the complaint and determine the cause of the problem stated to be sensor related.Suspect the sensor not able to be balanced possibly attributed to the drift failure, although not confirmed.
Additional Manufacturer Narrative
Corrected field h1 (serious injury).
Event or Problem Description
N/a.

• Brand Name: ICP SENSOR CATHETER 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: 19621043
• Report Number: 3014334038-2024-00135
• Device Sequence Number: 20863542
• Product Code: GWM
• UDI-Device Identifier: 10381780520436
• UDI-Public: 10381780520436
• Combination Product (Y/N): N
• PMA/510(K) Number: K991222
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2025

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: 826633
• Device Lot Number: 7058599
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 03/06/2025; 06/18/2025
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 03/28/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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