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

Catalog Number	823164
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that after implantation of a hakim valve (id 823164) during procedure, cerebrospinal fluid (csf) did not flow out.The valve was replaced, and the flow occurred without any issues after the replacement.The event happened before implantation site closure, no patient injury reported; however, the event led to 30 minutes surgical delay.
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
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823164) was returned for evaluation.Device history record (dhr) - the product code 82-3164 with lot 7204544, conformed to the specifications when released to stock.Failure analysis ¿ the position of the cam when valve was received was on setting 70 mmh2o.The valve was visually inspected; no defect was noted.The valve passed the test for programming, occlusion, reflux and pressure.The valve was leak tested; no leak was noted.The valve functions.Root cause analysis - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.However, the possible root cause for the issue reported by the customer can be due to the presence of air bubbles who can reduce the cross-sectional area of the flow path, increase system resistance, and impede the flow of fluid through the system during testing, as noted in the instruction for use (ifu).

• Brand Name: PROG VALVE INLINE
• 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: 20694709
• Report Number: 3013886523-2024-00359
• Device Sequence Number: 6471199
• Product Code: JXG
• UDI-Device Identifier: 10381780519249
• UDI-Public: (01)10381780519249(17)280331(10)7204544
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/07/2025

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: 823164
• Device Lot Number: 7204544
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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