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

Catalog Number	821730C
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2024
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.
Event or Problem Description
It was reported: "when nurse took over at 7 pm, the patient's evg was clogged again (this had already happened many times and was unclogged with actilysis and water for injection) - therefore non-permeable and nonreactive inferior intermediate pupils (known).Attempt to unblock at 9pm with actilyse (which had already taken place at 6pm with water for injection) then clamping for 2h (on oral medical request) - but before the two hours of clamping - patient's intraventricular pressure increased.Nurse doubts whether to record (take into account) the ivp value, as it is potentially unreliable due to the introduction of actilysis - physician came to the room and was concerned of the number, so the zero of the evd was carried out by nurse twice = > ivp at 6 = > so less stress for nurse and physician but as the evd has not presented a ¿beautiful¿ trace and therefore was not very reliable.Nurse and physician warned since the first evd obstructions).Around 7 p.M.-8 p.M.And 9 p.M.: lower intermediate and unreactive pupils then around 10-11 p.M.(10:45 p.M.Precisely on second check of the pupils on the unreliability of the equipment: dve): upper intermediate pupils see mydriasis and unreactive = > nurse warned.At the end, given the unreliability of the equipment, choice of icp placement in room = > shows high intracranial pressure.".
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The eds3 drainage system was not returned for evaluation; therefore, an evaluation of the device could not be performed.A list of lot numbers were provided as traceability, 3 of them were chosen for device history record (dhr) review (b)(4), all were conformed with specifications when released to stock.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: 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: 21095539
• Report Number: 3013886523-2025-00005
• Device Sequence Number: 9161561
• Product Code: JXG
• UDI-Device Identifier: 10381780521020
• UDI-Public: 10381780521020
• 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): 05/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 821730C
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 04/19/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown