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

Model Number	37.550.501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Vomiting (2144)
Date of Event	11/29/2022
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.(b)(4).
Event or Problem Description
Clinical study: a cerebroflo evd catheter was removed on (b)(6) 2022.Patient later complained of headache, nausea and vomiting, was hypertensive to 191/95, and was febrile to 103.3.Csf cultures remained negative but csf studies with low glucose, protein and high tnc (total nucleated cell count) were concerning for ventriculitis.Antibiotics administered started on (b)(6).Shunt implantation was delayed and patient was discharged until csf cultures remain negative and antibiotic therapy administered.Can occur with any evd catheter.According to clinical study investigator and integra's medical safety: adverse event is definitely related to procedure, possibly related to the device.
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.
Event or Problem Description
N/a.

• 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 ; 6099362319
• MDR Report Key: 16062432
• Report Number: 3014334038-2022-00290
• Device Sequence Number: 16655331
• 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
• Report Date (Section B): 03/28/2023

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?: 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): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/28/2023
• 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
• Patient Sex: Unknown