MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV INLIN/SG INTEGRAL CON; INTERNAL CSF DRAINAGE

Catalog Number	823842
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	12/04/2025
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
A physician reported a hakim valve (id 823842) was implanted due to congenital hydrocephalus via ventriculoatrial (va) shunt in 2017 with unknown setting.In 2025, the patient developed ventricular dilatation.Shunt dysfunction was suspected, therefore, the device was explanted and replaced on (b)(6) 2025.Based on information provided it is unknown the specific shunt dysfunction.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h11.The hakim valve (id 823842) was returned for evaluation.Device history review: the product code 82-3842 with lot 123733 conformed to specifications when released to stock.Failure analysis: the position of the cam when the valve was received was at 40 mmh2o.The valve was visually inspected; no defect was noted.The valve failed the test for programming, pressure and magnets.The valve was leak tested and failed, leaked from the housing.The valve passed the test for programming, occlusion, reflux and siphonguard.The valve was dismantled and examined under microscope at appropriate magnification: biological debris was noted on the plate, ball seat and the ruby ball.Root cause analysis: the root cause for the reported issue, pressure issue and programming issue observed during investigation, is due to biologicals debris, as noted in ifu: accumulation of biological matter (i.E.Blood, protein accumulations, tissue fragments, etc.) in the programming mechanism can cause inability of the device to be reprogrammed.Clogging of the programmable valve with biological matter can cause the valve to become unresponsive to attempts to change the pressure setting.Complications of implanted shunt systems include mechanical failure, shunt pathway obstruction, infection, foreign body (allergic) reaction to implants, and csf leakage along the implanted shunt pathway.The root cause for the leakage issue observed during investigation is due to human misuse, as noted in ifu: silicone has a low cut and tear resistance; therefore, exercise care when placing ligatures so as not to tie them too tightly.The use of stainless steel ligatures on silicone rubber is not recommended.Do not use sharp instruments when handling the silicone valve or catheter; use shod forceps.Cuts or abrasions from sharp instruments may rupture or tear the silicone components.

• Brand Name: CHPV INLIN/SG INTEGRAL CON
• 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: 23942934
• Report Number: 3013886523-2025-00339
• Device Sequence Number: 15422468
• Product Code: JXG
• UDI-Device Identifier: 10886704041856
• UDI-Public: (01)10886704041856(17)220131(10)123733
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 01/31/2022
• Device Catalogue Number: 823842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2017
• 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: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male