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

Catalog Number	823832
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2024
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.The full name of the reporting facility is (b)(6).
Event or Problem Description
A facility reported that a hakim valve/prog valve inline w sg ((b)(6)) was implanted on (b)(6) 2023.Several months later, the physician found that the valve could not be programmed.On march 9, 2024, the physician performed a revision procedure and discovered that no cerebrospinal fluid (csf) was flowing out of the abdominal catheter and suspected that the valve was blocked.The physician retrieved the valve and replaced it with a new hakim valve (823832).It was reported that the patient¿s current status is stable.There were no delays and no adverse consequences.
Additional Manufacturer Narrative
Updated fields: d4 (udi# and expiration date) d9, g3, g6, h2, h3, h4, h6, h11 the suspected hakim valve (id 823832) was returned for evaluation.The device history record (dhr) was reviewed and the product code 82-3832 with lot 6920575 conformed to the specifications when released to stock.Failure analysis - the position of the cam when the valve was received was on setting 80 mmh2o.Upon visual inspection, it was noted that needle guard was dislodged and there was a needle hole in the needle chamber.The valve was hydrated.The valve was tested for programming and the test failed.The flush, pressure and leak tests could not be performed as the needle guard was dislodged.The valve was reflux tested, siphon guard was tested, and both passed.The valve was disassembled and visually inspected under microscope at appropriate magnification: biological debris was found on the ruby ball, on the seat of the ruby ball and motor.A visual control magnetizing engines was performed; 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 instruction for use 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 an unintentional setting change.The possible root cause for the needle guard dislodged, could be due to improper handling of the device.

• 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 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: 19247495
• Report Number: 3013886523-2024-00127
• Device Sequence Number: 20660405
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: 10381780519805
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• 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,Company Representative
• Initial Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823832
• Device Lot Number: 6920575
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 MO
• Patient Sex: Female