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

Catalog Number	826653
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
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 a microsensor (id 826653) was implanted and was leaking cerebrospinal fluid (csf).The issue was detected during procedure, before implantation site closure and the event led to 15 minutes surgical delay.The procedure was completed with a replacement product available.The patient is in stable condition.The microsensor was used with icp express monitor (id 826635) and icp express cable (id 826635).
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The microsensor (id 826653) was returned for evaluation.Device history record (dhr) - review was performed on reported lot number 7121748, and no anomalies were identified during the manufacture or packaging of the device.However, the returned device for failure analysis doesn¿t match the reported lot number.Therefore, we have reviewed dhr and kitting dhr for returned device¿s lot number 7249996 and no anomalies were identified during the manufacture or packaging of the device.Failure analysis - the returned product didn't match with reported kitted dhr lot number.The returned unit was inspected.The catheter was inspected.It was observed that the stopcock fitting was improperly attached to the catheter.The catheter has a male luer that should be attached to a female luer (per ifu).A syringe with water was connected to the catheter.The catheter tip was clamped, and pressure was applied with the syringe.No leakage was observed.The complaint was not confirmed.Root cause analysis - a potential root cause of the issue is a user error due to incorrect component pairing: a male luer stopcock was used instead of the required female luer connector as specified in the ifu.
Event or Problem Description
N/a.

• 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 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: 19669880
• Report Number: 3014334038-2024-00139
• Device Sequence Number: 6851277
• 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): 10/27/2025

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 Catalogue Number: 826653
• Device Lot Number: 7249996
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ICP EXPRESS CABLE (ID 826635); ICP EXPRESS MONITOR (ID 826635
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian