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

Model Number	823110
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id 823110) could not be programmed and was explanted.The valve was implanted on (b)(6) 2022.When the medical staff tried to program the valve at high pressure level (180), the valve did not respond.Medical staff tried to program with all hakim programmers available in the hospital (3).None of them succeeded.The valve was explanted and replaced on (b)(6) 2022.
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
Hakim valve was returned for evaluation: dhr - lot 5611485, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; biological debris was noted in the valve mechanism.The valve failed the tests for reflux and pressure.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was noted on the spring, on the ruby ball and on the seat of the ruby ball.The valve passed the tests for programming, occlusion, leaks.Root cause - no root cause could be determined as the technician could not confirm any programing issues with the valve at the time of 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 mechanism, but at the time of investigation no programing issues were noted with the valve.The root cause for the reflux and pressure issues noted during the investigation is due to biological debris found on the ruby ball and the seat of the ruby ball.

• Brand Name: PROG VALVE CLYNDRICAL W PRECHA
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15926138
• Report Number: 3013886523-2022-00564
• Device Sequence Number: 5054209
• Product Code: JXG
• UDI-Device Identifier: 10381780519133
• UDI-Public: (01)10381780519133(17)260531(10)5611485
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 03/09/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: 823110
• Device Catalogue Number: 823110
• Device Lot Number: 5611485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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 Age: 64 YR
• Patient Sex: Female