MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD EDS3 DRAINAGE SYSTEM; CSF DRAIN SYS/CRANIAL ACCESS

Catalog Number 821730C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Vomiting (2144); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 07/20/2023

Event Type  Injury  

Event Description

A facility reported a patient was having a mri exam.Accidental injection of gadolinium into an external ventricular derivation instead of injecting it intravenously.Even if it is an error, this injection was possible because of the absence of different specific connectivity between intravenous way and evd.State of the patient: loss of consciousness and convulsion, transfer to intensive care department.Actions taken by hospital : gadolinium was re-aspirated.Patient was monitored in intensive care.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The eds3 drainage system was not returned for evaluation (as per customer, product not available); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause for the issue reported by the customer is due to user error, the patient line has a green strip as well as a tag that identifies the line as ¿csf¿ in addition there is a warning in the ifu regarding use of the needle-free sampling/injection site.¿care must be taken when administering medication through these locations to minimize the chance of intravascular medication being injected into the cerebrospinal fluid.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 information received: the patient is stable as he was before the incident.Immediate consequences for the patient : sudden headache, immediate vomiting and loss of consciousness.Generalized convulsive attack lasting a few minutes to 30 minutes after the injection.Hospitalization in intensive care for monitoring.Return to pre-incident state in 2-3 days.Long term consequences : not known.No related events since the incident.Patient : male / 19 years old.The incident was detected before the beginning of the exam.Drainage system placement when the incident occurred: the evd valve/tap was at the patient's neck on the right.The central line/catheter was on the left.The mri antenna and a sheet covered the rest of the device at the level of the patient's head and the collection bag was clamped placed on the patient's legs.It is not suspended at the back as expected for this purpose.Absence of the case to hide the injection site (material not available in the intensive care unit on the day of the mri).The injection of gadolinium was realized at needle-free sampling/injection site.Injection was realized by medical team in radiology and this person was trained how to handle patient with drainage system as evd3.

• Brand Name: EDS3 DRAINAGE SYSTEM
• 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: 18300790
• MDR Text Key: 330165258
• Report Number: 3013886523-2023-00436
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K172537
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 821730C
• Device Lot Number: 708-25-87
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2024
• Date Device Manufactured: 03/24/2023
• 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
• Patient Age: 19 YR
• Patient Sex: Male