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

Catalog Number	823115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/16/2024
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 sales representative reported: "on (b)(6) 2022, the patient had hydrocephalus symptoms and a destroyed mechanism was seen on x-ray.They talked about it as part of a further training course." the valve was implanted on (b)(6) 2013; explanted and replaced on (b)(6) 2024.The boy has had a total of 7 mris in his life, the last one was on (b)(6) 2024.The valve defect also occurred during this time.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The hakim valve was returned for evaluation: dhr - lot cpkb4k, conformed to the specifications when released to stock failure analysis - the valve was visually inspected; stator was dislodged.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification : biological debris was found on the motor and on the ruby ball.Traces of corrosion have been identified on stator.A visual control magnetizing engines was done, a normal polarization was noted.Root cause - -the root cause for the problem reported by the customer is due to the corrosion of the mechanism linked to the accumulation of biological debris which has weakened and destroyed the mechanism.The root cause for the programming issue is due to biological debris and protein build up interfering with the valve in view of the biological debris found during the investigation.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE CLYNDRICAL
• 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 08540 ; 6099362319
• MDR Report Key: 18841821
• Report Number: 3013886523-2024-00067
• Device Sequence Number: 7216085
• Product Code: JXG
• UDI-Device Identifier: 10886704041504
• UDI-Public: (01)10886704041504(17)180731(10)CPKB4K
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2024

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: 07/31/2018
• Device Catalogue Number: 823115
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 06/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2013
• 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 Sex: Unknown