MAUDE Adverse Event Report: RAYNHAM CEREBROFLO EVD CATHETER KIT; NEURO

Model Number	37.550.501
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2022
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
Clinical study: "evd clogged and required replacement with lf cerebroflo evd on (b)(6) 2022.Evd again clogged on (b)(6) 2022 and lumbar drain was placed.Stereotactic rf evd was replaced on (b)(6) 2022." patient status: recovered.
Additional Manufacturer Narrative
The cerebroflo evd catheter kit (37550101) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.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.
Additional Manufacturer Narrative
Updated fields a3a, d9, g3, g6, h2, h3, h11.Additional information received: patient birth year: 1953.Patient gender: m (male).Ae relationship to device: probably.Ae relationship to procedure: unrelated.Was unanticipated? anticipated.Outcome: recovered/resolved without sequelae0 resolution date: 29-jul-2022.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6 h11.Additional information received: updated adverse event causality as per clinical study investigator: adverse event is unrelated to the device; unrelated to study procedure.Updated adverse event adjudication by integra medical safety: adverse event is unrelated to the device; unrelated to study procedure.Adverse event is unrelated (evd re-placement) to the initial cerebroflo evd placement on 7/4/2022.

• Brand Name: CEREBROFLO EVD CATHETER KIT
• Common Device Name: NEURO
• 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: 16019578
• Report Number: 3014334038-2022-00284
• Device Sequence Number: 5896940
• Product Code: JXG
• UDI-Device Identifier: 10381780530138
• UDI-Public: 10381780530138
• Combination Product (Y/N): N
• PMA/510(K) Number: K170599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/06/2026

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 Model Number: 37.550.501
• Device Catalogue Number: 37550101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 03/08/2023; 10/08/2025; 01/21/2026
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 03/28/2023; 10/31/2025; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Male