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

Catalog Number	823834
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Headache (1880)
Date of Event	05/21/2025
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 823834) was implanted in 2018.In (b)(6) 2025, the patient presented with headache, and there was a total block of drainage, therefore, due to suspicion of obstruction, it was removed and replaced.When the valve was explanted it was found to be broken.The patient recovered.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve was returned for evaluation: dhr - conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; connector was disassembled from the housing.The valve failed the tests for programming, and occlusion.The valve passed the tests for leaks and reflux.The valve was pressure tested, the valve failed the test at 160mmh2o and the others settings could not be tested as the valve not program.The valve was disassembled and visually inspected under microscope at appropriate magnification: biological debris was found on the spring, on the ruby ball, sear of ruby ball and on the base plate.Root cause - -the root cause for the issue reported by the customer is due to biological debris and protein build up interfering with the valve, at the time of investigation biologicals debris were found.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE
• Common Device Name: CHPV
• 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: 22283337
• Report Number: 3013886523-2025-00154
• Device Sequence Number: 12876311
• Product Code: JXG
• UDI-Device Identifier: 10381780519812
• UDI-Public: (01)10381780519812(17)270228(10)6263541
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: 823834
• Device Lot Number: 6263541
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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 Age: 22 YR
• Patient Sex: Unknown