MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number	823162
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id 823162) was implanted due to congenital hydrocephalus via ventriculoperitoneal (vp) shunt on unknown date with unknown setting.The valve was removed and replaced on (b)(6) 2025, due to suspicion of obstruction.According to the information provided, it is unknown if the patient experienced any signs and symptoms due to product problem.
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: g3, g6, h11.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the reported issue could be due to biologicals debris, as mentioned 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the product code 82-3162 with lot 7356566 conformed to the specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at setting 110 mmh2o.The valve was visually inspected, no defect was noted.The valve passed the test for programming, occlusion, leak, reflux, siphon guard and pressure.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the reported issue could be due to biologicals debris, as mentioned in the ifu, accumulation of biological matter within the valve can cause difficulties adjusting the valve setting with the tool kit, and impair the anti-reflux function.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• 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: 23154787
• Report Number: 3013886523-2025-00258
• Device Sequence Number: 14775086
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)290228(10)7356566
• 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,Followup
• Report Date (Section B): 01/02/2026

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 Catalogue Number: 823162
• Device Lot Number: 7356566
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 12/11/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/26/2025; 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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: Required Intervention
• Patient Age: 12 YR
• Patient Sex: Female