MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICROSENSOR VENTRICULAR CATHETER KIT; ICP MICROSENSORS (ROHS)

Catalog Number	826653
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that during pre- testing, a microsensor (id 826653) could be zeroed normally and it could monitor the icp readings normally during the procedure.However, a while after the patient was sent back to ward, the icp monitor showed"p-0" repeatedly.Then the physician changed with another cable and icp monitor to reconnect with the microsensor, it still showed"p-0".Therefore, the problem was with the microsensor.The physician retrieved the microsensor and stopped monitoring.The microsensor was used along with icp monitor (id 826653) and icp cable (id 826636).
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.
Additional Manufacturer Narrative
The ventricular catheter (id 261221) was returned for evaluation.Device history record (dhr) ¿ there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the catheter was received in a drainage tube.When connected, the icp express read ¿zeroing error¿, output of the sensor was no longer balanced, and the electrical leakage test failed.The complaint could be verified through failure analysis.Root cause analysis ¿ the complaint was confirmed in the complaint investigation.A potential root cause to the zeroing issue is the electrical leakage ¿ use related.This cannot be confirmed, but the root cause is a potential cause.

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Common Device Name: ICP MICROSENSORS (ROHS)
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 18192579
• Report Number: 3014334038-2023-00180
• Device Sequence Number: 15270044
• Product Code: GWM
• UDI-Device Identifier: 10381780520566
• UDI-Public: 10381780520566
• Combination Product (Y/N): N
• PMA/510(K) Number: K991222
• 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): 06/26/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 826653
• Device Lot Number: 6248689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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 CABLE (ID 826636).; ICP MONITOR (ID 826635).
• Patient Sex: Unknown