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

Catalog Number	823115
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Vomiting (2144); Discomfort (2330)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hakim valve was returned for evaluation: dhr - lot 6147243, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; no defect was noted.The valve was tested for programming: the valve failed the test.The valve passed the tests for occlusion, leaks, reflux and pressure.The valve was disassembled and visually inspected under microscope at appropriate magnification: biological debris were found on the ruby ball, on the seat of the ruby ball and motor.Root cause - 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 as biological debris were found during the investigation.
Event or Problem Description
A facility reported a hakim valve (id 823115) was implanted on (b)(6) 2023.Approximately 6 months after implantation, the patient showed repeated phases of vomiting, discomfort and drowsiness.The imaging showed narrow ventricles, so medical staff suspected overdrainage.The valve opening pressure was adjusted, and the patient felt better, with a drop in the "az" in the days that followed.Therefore, the valve was removed and replaced with a hakim valve with siphonguard on (b)(6) 2024.The patient recovered.

• Brand Name: PROG VALVE CLYNDRICAL
• 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: 20150907
• Report Number: 3013886523-2024-00270
• Device Sequence Number: 4248054
• Product Code: JXG
• UDI-Device Identifier: 10381780519188
• UDI-Public: (01)10381780519188(17)261231(10)6147243
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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: 823115
• Device Lot Number: 6147243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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 Sex: Unknown