MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV I-L/S W/PLAT UN120CM DIST; CHPV WITH SG

Catalog Number	823854
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2024
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 facility reported a hakim valve (id 823854) was implanted few months ago and was set at 120mmh20.Few months after implantation the physician wanted to adjust the shunt setting using a hakim programmer.However, the valve did not reprogram and was stuck at 120mmh20.They used multiple programmers and utilized x-ray to confirm the valve setting.Therefore, the valve was removed and replaced on (b)(6) 2024.
Additional Manufacturer Narrative
The hakim valve (id 823854) was returned for evaluation.Device history record (dhr) - the product code 826854 with lot 7330099 sn n/a, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 120 mmh2o.The valve was visually inspected: no defect was noted.The valve passed the test for occlusion, reflux and pressure the valve failed the test for programming.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the ruby ball, motor and on the seat of the ruby ball.Root cause analysis - the root cause for the programming and occlusion issues are due to biological debris and protein build up interfering with the valve.
Event or Problem Description
N/a.

• Brand Name: CHPV I-L/S W/PLAT UN120CM DIST
• Common Device Name: CHPV WITH SG
• 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: 20694707
• Report Number: 3013886523-2024-00356
• Device Sequence Number: 15075351
• Product Code: JXG
• UDI-Device Identifier: 10381780535119
• UDI-Public: (01)10381780535119(17)281031(10)7330099
• Combination Product (Y/N): N
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823854
• Device Lot Number: 7330099
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HAKIM PROGRAMMER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown