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

Catalog Number	823832
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	03/15/2025
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 facility reported a hakim valve (id 823832) was implanted on (b)(6) 2025.The patient had a computed tomography (ct) check on (b)(6) 2025, and the valve was at the proper position.On (b)(6) 2025, the patient was found with underdrainage and the ventricle was enlarged.Therefore, the valve was removed and replaced.The patient is stable.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823832) was returned for evaluation.Device history record (dhr) - the product code 82-3832 with lot 7302945 conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at 60 mmh2o.The valve was visually inspected; no defaults were observed.The valve was hydrated.The failed the test for programming: the cam mechanism wiggled.The valve passed the test for occlusion, leak, reflux and siphon guard.The pressure test could not be performed because the device could not be programmed.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification; biological debris were found on the seat of the ruby ball and motor.Root cause analysis - the root cause for the issue reported by the customer, is due to biological debris and protein build up interfering with the valve in view of the biological debris found during the investigation.

• 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: 21773362
• Report Number: 3013886523-2025-00070
• Device Sequence Number: 15503845
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)281031(10)7302945
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823832
• Device Lot Number: 7302945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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: 19 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian