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

Catalog Number	823162
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id 823162) was implanted due to congenital hydrocephalus via ventriculo-peritoneal (vp) shunt on an unknown date with an unknown setting.On (b)(6) 2025, the device was explanted and replaced with a new device due to shunt dysfunction.The patient recovered.According to information provided, the valve failure is unknown.It is also unknown if the patient presented with signs and symptoms of valve malfunction.
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: d4, d8, d9, g6, h1, h2, h3 h4, h6, h11.The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the product code 823162 with lot 6644941 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at setting 120mmh2o.The valve was visually inspected: no defect noted.The valve passed the test for leak, reflux, and siphonguard.The valve failed the test for programming and occlusion.The catheter was tested, and no occlusion was noted.The pressure test could not be performed as valve could not be programmed.Biologicals debris were observed on the ruby ball, spring and motor.Root cause -the root cause for the reported issue and programming issue is due to biological debris and protein build up interfering with the valve in view of the biological debris found during the investigation.
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: 22311211
• Report Number: 3013886523-2025-00161
• Device Sequence Number: 12964768
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)270731(10)6644941
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 6644941
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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 Sex: Unknown