MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD VENT RES TR RICKHAM LG BA; INTERNAL CSF DRAINAGE

Catalog Number	821623
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2026
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
Study - this case refers to an approximately 11-old male participant.An investigator reported this case from the biomarin sponsored study, cerliponase alfa observational study."on 12-sep-2019, the participant underwent implantation of intracerebral ventriculostomy (icv) set (rickham, codman).The catalog and model number were 82-1623.The lot number was 3693875 and the serial number was unknown." "on 12-sep-2019, the participant was initiated on treatment with brineura (300 milligram, qow, intracerebroventricular use).The lot number for brineura was not reported.The most recent dose was administered on 20-jan-2026." "on 20-jan-2026, the participant's brineura infusion was administered from 08:30 to 13:00.At 14:30, the participant developed a grade 3 intraventricular reservoir leak.There was leaking seen from the infusion site.The participant was subsequently hospitalized due to the event.On 21-jan-2026, the device was successfully replaced with a power port slim implantable port, 6f single lumen.The event occurred at the clinic, and the device is not available for return.No laboratory or diagnostic tests were reported.No treatment for the event was reported.No action was taken with brineura due to the event." "the outcome of the event was reported as recovered/resolved on 23-jan-2026 at 14:34." "the investigator assessed the event of device leakage as not related to treatment with brineura.The investigator assessed the event of device leakage as related to the participant's icv device.Other etiological factors included the device was well past its expected life.".
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The catheter (id 821623) 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.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 corrective and preventative action (capa) was initiated and ifu was updated.Changes done: update of section with catalog number, update injection section (precaution of 25 punctions max in the dome, at multiples, locations, to avoid any risk of tearing), correct ec rep address, update section about trademarks, add website.

• Brand Name: VENT RES TR RICKHAM LG BA
• Common Device Name: INTERNAL CSF DRAINAGE
• 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: 24400468
• Report Number: 3013886523-2026-00024
• Device Sequence Number: 20866246
• Product Code: JXG
• UDI-Device Identifier: 10886704040514
• UDI-Public: (01)10886704040514(17)240331(10)3693875
• Combination Product (Y/N): N
• PMA/510(K) Number: K102961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 821623
• Device Lot Number: 3693875
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN (PARACETAMOL); AMOXICILLIN TRIHYDRATE/ CLAVULANATE POTASSIUM; BACLOFEN (BACLOFEN); BACTROBAN (MUPIROCIN) 06/10/2021; CLOBAZAM (CLOBAZAM); CLONAZEPAM (CLONAZEPAM); DEPAKOTE (VALPROATE SEMISODIUM); DIAZEPAM (DIAZEPAM); DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE); DIVALPROEX (VALPROATE SEMISODIUM); GLYCOPYRROLATE (GLYCOPYRRONIUM BROMIDE; LEVETIRACETAM (LEVETIRACETAM); LIDOCAINE AND PRILOCAINE (LIDOCAINE, PRILOCAINE); LORAZEPAM (LORAZEPAM); MIDAZOLAM (MIDAZOLAM HYDROCHLORID); POLYETHYLENE GLYCOL (MACROGOL)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male