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

Catalog Number	823162
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id (b)(6)) was implanted due to congenital hydrocephalus via ventricular peritoneal (vp) shunt with unknown setting in 2018.On (b)(6) 2024, when attempting to change the setting, it could not be changed even under fluoroscopic guidance.Therefore, a revision surgery was performed.The valve was replaced with a certas valve (unknown product id).The patient's primary disease was spina bifida.The patient is currently in follow- up.According to information provided, it is unknown if the patient experienced any signs and symptoms due to valve issue.
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 (id 823162) was returned for evaluation.Failure analysis - the position of the cam when valve was received was on setting 40 mmh2o.The valve was visually inspected; no defect was noted.The valve passed the test for occlusion, siphon guard and reflux.The valve was leak tested; no leak was noted.The valve failed the test for programming and pressure.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris were found on the motor on the seat of the ruby ball.A visual control magnetizing engines was done; an abnormal polarization was noted.Root cause analysis - the root cause of the programming issue reported by the customer has been identified as biological debris and protein buildup interfering with the valve, as discovered during the investigation.The possible root cause for the abnormal polarization noted during the investigation, could be due to improper use of mri, as noted in the instructions for use (ifu): any magnet may experience a degradation of magnetic field strength as a consequence of exposure to the significantly stronger magnet field induced in an mri procedure.However, magnetic fields should not be placed near the valve due to the possibility of unintentional setting change.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• 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 08540 ; 6099362319
• MDR Report Key: 19160788
• Report Number: 3013886523-2024-00113
• Device Sequence Number: 7855453
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: 10381780519232
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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 Catalogue Number: 823162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 8 YR
• Patient Sex: Female