MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV RT ANG RESERVOIR UNITIZED

Catalog Number	823148
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported a hakim valve malfunction.The patient's medical history included surgery 8 months ago.On an unknown date, the patient had visited the hospital for reprogramming of shunt, and during the reprogramming of the shunt, the pressure at the xray was seen to 30 instead of 90 and the reprogramming was done twice for 90 but the pressure setting was showing 30.At the time of the reporting, the outcome of the event malfunction of shunt was unknown.
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 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.A possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the device.However, 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve was not returned for evaluation, however, a photo was provided showing the device at setting 30mmh2o, but it could not be confirmed if the valve would not program.
Additional Manufacturer Narrative
Updated fields: d1.D2a, d4, g3, g6, h2, h3, h11 device history record (dhr) update - review of the history device records was not possible as the lot number is unknown.Product code 82-3148 udi:(b)(4).

• Brand Name: CHPV RT ANG RESERVOIR UNITIZED
• 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: 19589808
• Report Number: 3013886523-2024-00182
• Device Sequence Number: 16972799
• Product Code: JXG
• UDI-Device Identifier: 10381780519225
• UDI-Public: 10381780519225
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 10/02/2024; 03/04/2025
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/20/2024; 10/24/2024; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown