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

Catalog Number	823162
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2024
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 physician reported a hakim valve (id (b)(6)) was implanted due to non-communicating hydrocephalus via ventriculoperitoneal (vp) shunt on (b)(6) 2019 with unknown setting.The pressure setting could not be changed; therefore, the device was explanted and replaced with a new device on (b)(6) 2024.The physician pulled out the device and damaged it during revision surgery.According to information provided, the initial and the desired setting are unknown.It is unknown if the patient experienced any signs and symptoms due to device issue.The patient has recovered.
Additional Manufacturer Narrative
The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) ¿ the product code 823162 with lot 3276906 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 140 mmh2o.The valve was visually inspected; the siphon guard was broken, and the needle chamber was torn.The valve was hydrated.Leak was noted from the back of the needle guard.The valve failed for programming, occlusion and reflux.The pressure test could not be performed as the device could not be programmed.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the ruby ball, motor and on the seat of the ruby ball.Root cause analysis - the root cause for the programming and occlusion issues are 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: 20369151
• Report Number: 3013886523-2024-00312
• Device Sequence Number: 19805714
• Product Code: JXG
• UDI-Device Identifier: 10886704041559
• UDI-Public: (01)10886704041559(17)231031(10)3276906
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 823162
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2018
• 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: 6 YR
• Patient Sex: Female