MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number	XXX-HAKIM PROGRAMMABLE VALVE
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2024
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 (unknown id) ceased to drain.Therefore, the physician implanted a new valve from a different brand.The patient is doing well.No additional information was provided after several attempts.
Additional Manufacturer Narrative
The hakim valve (unknown id) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to biological debris and protein build up interfering with the device.But it was not possible to confirm and identify the root cause of this assumption as the product was not returned for investigation.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (unknown id) was returned for evaluation.Failure analysis - the position of the cam when valve was received was on setting 30 mmh2o.The valve was visually inspected and a needle hole in the needle chamber was noted.The valve was hydrated.The valve failed the test for programming, the cam mechanism wiggled.The valve was leak tested and no other leak than the needle holes in the needle chamber was noted.The valve passed the test for occlusion and reflux.The pressure test could not perform as the device cannot be programmed.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification; biological debris was found on motor and on the seat of the ruby ball.Root cause analysis - no root cause could be determined as the technician could not confirm any drainage issues with the valve at the time of the investigation.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve in view of the biological debris found during the investigation.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• 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: 19893076
• Report Number: 3013886523-2024-00221
• Device Sequence Number: 15267582
• Product Code: JXG
• UDI-Device Identifier: 10886704041467
• UDI-Public: 10886704041467
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: XXX-HAKIM PROGRAMMABLE VALVE
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 09/06/2024; 04/01/2025
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 09/20/2024; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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