MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VAVLE MICRO W RICKHAM; INTERNAL CSF DRAINAGE

Catalog Number	823116
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2026
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
A facility reported a hakim valve (id 823116) was implanted on (b)(6) 2026, due to hydrocephalus.The valve adjustment failed and the physician made a multiple attempt more than 2-3 times to adjust without success.Two different adjustment tools were used, but neither worked.It was confirmed that the unit was defective.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valva (id 823116) was returned for evaluation.Device history record (dhr) - the valves, product code 82-3116 with lot 7396735 conformed to specifications when released to stock.Failure analysis - the position of the cam when valve was received was at 11mmh2o.The valve was visually inspected; tear observed on the housing.The valve failed the test for programming (cam was blocked at 110mmh2o), occlusion and leak tests (leaked from the siphon guard).Also failed the test for pressure.The valve was dismantled and observed under microscope: biologicals debris noted on the ball seat, cam and plate.Cut observed on the housing the magnets has been tested: failed, no magnetization observed.The magnets were separated from the cam.Root cause analysis - the root cause for the leakage issue is due to human misuse as noted in ifu: silicone has a low cut and tear resistance; 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.The root cause for the programming could be due to biologicals debris observed on the plate and seat ball, as noted in ifu: the root cause for the reported issue could be due to biologicals debris, as noted in the 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.Another potential root cause for programming issue could be due to improper use of mri, as noted in the ifu: any magnet may experience a degradation of magnetic field strength as a consequence of exposure to the significantly stronger magnet field induced in an mri procedure.However, magnetic fields should not be placed near the valve due to the possibility of an unintentional setting change.The root cause for the magnets separated from the cam: during the valve disassembly, when the technician lifted the cam, one magnet remained stuck to the plate, and all the others clustered onto it due to the weakening of the epoxy after exposure to an excessively strong mri.

• Brand Name: PROG VAVLE MICRO W RICKHAM
• 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: 24647786
• Report Number: 3013886523-2026-00065
• Device Sequence Number: 9842141
• Product Code: JXG
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 823116
• Device Lot Number: 7396735
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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
• Patient Race: Asian