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

Catalog Number	821730C
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported: "during an emergency surgical procedure performed on a patient with a diagnosis of serious illness, subaranoid intraventricular hemorrhage of aneurysmal origin with acute hydrocephalus, the codman external drainage system (id 821730c) is opened to be used and the absence of the device to fix the drainage system is evident.However, due to the urgency, it is fixed only with suture, which at the end of the surgical process, the system comes off and it is not possible to reoperate on the patient." additional information received: "the patient died due to her critical condition" and confirmed by the distributor: "the device failure was not the cause of the dead of the patient.".
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11 the eds drainage system (id (b)(4)) was not returned for evaluation; 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(s) of the reported issue could not be determined, however, the root cause for the issue reported by the customer could be due to a user¿s error.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.

• Brand Name: EDS3 DRAINAGE SYSTEM
• Common Device Name: CSF DRAIN SYS/CRANIAL ACCESS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21306616
• Report Number: 3013886523-2025-00006
• Device Sequence Number: 8020266
• Product Code: JXG
• UDI-Device Identifier: 10381780521020
• UDI-Public: (01)10381780521020(17)260831(10)7282421
• Combination Product (Y/N): N
• PMA/510(K) Number: K172537
• 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): 04/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 821730C
• Device Lot Number: 7282421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic