MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV CYL W/LG RR NU120CM DIST

Catalog Number	823852
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Headache (1880)
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 823852) was implanted on (b)(6) 2012 via ventriculoperitoneal (vp) shunt.The valve malfunctioned and was not able to reset shunt prior to surgery, therefore it was explanted and replaced on (b)(6) 2024 due to inability to reprogram.The patient experienced positional headaches consistently with low pressure and is recovering well.
Additional Manufacturer Narrative
The hakim valve (id 823852) was returned for evaluation.Device history record (dhr) ¿ the product code 82-3852 with lot cmnc6d, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 130 mmh2o.The valve was visually inspected; no defect was noted.The valve was hydrated.The valve was tested for programming and failed; the cam mechanism wiggled.The valve passed the test for occlusion, leak and reflux.The pressure test could not be performed as the valve can't be programmed.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.A visual control magnetizing engines was done, an abnormal polarization was noted.Root cause analysis - the root cause for the issue reported by the customer, is due to biological debris and protein build up interfering with the valve in view of the biological debris found during the investigation.

• Brand Name: CHPV CYL W/LG RR NU120CM DIST
• 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: 18788692
• Report Number: 3013886523-2024-00052
• Device Sequence Number: 8343973
• Product Code: JXG
• UDI-Device Identifier: 10886704041887
• UDI-Public: (01)10886704041887
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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 Expiration Date: 11/30/2016
• Device Catalogue Number: 823852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2011
• 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: 41 YR
• Patient Sex: Male
• Patient Race: White