MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD EDS DRAINAGE SYS NO V CATH; CSF DRAIN SYS/CRANIAL ACCESS

Catalog Number	821731C
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Nausea (1970); Tachycardia (2095)
Date of Event	07/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported an accidental injection of radio contrast medium into the sampling/injection site of the ventricular shunt device in place of the vascular access.The contrast product was therefore injected into the cerebral ventricles.Patient presented with nausea, hypertension, tachycardia.The patient is an adult of approximately 60 years-old.The following days : general tonico-clonic crisis and hydrocephalus meningitis at pseudomonas & candida, septic vasculitis, ischemic stroke + appearance of stenosis.Long term: cognitive problems, left hypoesthesia, total dependence, continence and swallowing problems.Actions taken in the healthcare establishment to manage the patient: immediate management by the intensive care unit team.Patient has incapacitating sequela.
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.Other "health effect-clinical code" 2223, 3272, 2389, 4418, 2263, 2551, 2352, 1815.
Additional Manufacturer Narrative
The eds drainage system 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 is due to user¿s error, failure to adhere to ifu warning label regarding using the needle free sampling/injection site.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.A medical assessment was requested to our medical safety department with the following conclusion: use error.Failure to adhere to ifu label regarding using the needle-free sampling/injection site."warning" the eds3 system provides direct access to the ventricular drainage catheter via the patient line stopcock and the needle-free injection site.Care must be taken when administering medication through these locations to minimize the chance of intravascular medications being injected into the cerebrospinal fluid.".

• Brand Name: EDS DRAINAGE SYS NO V CATH
• Common Device Name: CSF DRAIN SYS/CRANIAL ACCESS
• 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 ; 6099362319
• MDR Report Key: 17694985
• Report Number: 3013886523-2023-00304
• Device Sequence Number: 6306434
• Product Code: JXG
• UDI-Device Identifier: 10381780518327
• UDI-Public: 10381780518327
• Combination Product (Y/N): N
• PMA/510(K) Number: K061568
• 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): 10/20/2023

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: 821731C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/20/2023
• 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