MAUDE Adverse Event Report: RAYNHAM ICP SENSOR CATHETER KIT; ICP MICROSENSORS

Catalog Number	826633
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	06/28/2023
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 an icp sensor (id 826633) was implanted on (b)(6) 2023 and one day after procedure, the physician found that there was cerebrospinal fluid (csf) leaking out from the luer-fitting of the microsensor (id 826633).The patient did not show any signs and symptoms due to csf leak.The microsensor was removed on (b)(6) 2023 and was not replaced.The patient is stable.
Additional Manufacturer Narrative
The micorsensor (id 826633) was not returned for evaluation after the three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a potential root causes include: improper cap tolerance, device misuse.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The sensor catheter kit was returned for evaluation: failure analysis - the icp sensor catheter kit was visually inspected.It was observed that only the microsensor was present.The catheter was not included.Root cause - the complaint was not confirm in the complaint investigation and failure analysis.Potential root causes include: improper cap tolerance, device misuse.
Event or Problem Description
N/a.

• Brand Name: ICP SENSOR CATHETER KIT
• Common Device Name: ICP MICROSENSORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 17397359
• Report Number: 3014334038-2023-00118
• Device Sequence Number: 12655459
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 826633
• Device Lot Number: 6396419
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 09/20/2023; 10/23/2025
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 10/04/2023; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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 CABLE (ID 826636).; ICP MONITOR (ID 826635).
• Patient Sex: Unknown