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

Catalog Number 821731C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems High Blood Pressure/ Hypertension (1908); Nausea (1970); Tachycardia (2095)

Event Date 07/04/2023

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 322801658
• Report Number: 3013886523-2023-00304
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780518327
• UDI-Public: 10381780518327
• Combination Product (y/n): N
• PMA/PMN Number: K061568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 821731C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1