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	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id 823162) was implanted on (b)(6) 2024.Two weeks after the procedure, the hydrocephalus of the patient didn't improve and the physician suspected that the valve was blocked.Therefore, on (b)(6) 2024, the physician conducted a procedure to retrieve the valve.
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
The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the product code 82-3162 with lot 6366261 conformed to the specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at setting 30 mmh2o.The valve was visually inspected; no defect was noted.The valve passed the test for programming, occlusion, leak, reflux and siphon guard.The valve was then pressure tested and failed.The valve was dismantled and examined under microscope at appropriate magnification: biological debris was noted on the housing, the motor and the ball.Root cause analysis - the root cause for the shunt dysfunction issues is due to biological debris and protein build up interfering with the valve.
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: 21067491
• Report Number: 3013886523-2024-00401
• Device Sequence Number: 15553357
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)270430(10)6366261
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 04/28/2025

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: 823162
• Device Lot Number: 6366261
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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: 11 YR
• Patient Sex: Male
• Patient Weight: 21 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian