MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CHPV INLIN/SG INTEGRAL CON; CHPV WITH SG

Model Number	82-3842
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	03/27/2022
Type of Reportable Event	Malfunction
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
This is 2 of 2 reports linked to mfg report numbers: 3013886523-2022-00157.A physician reported two hakim valves were implanted in a (b)(6) year-old female patient via v-p shunt in 2020 with unknown setting.Both valves were implanted at the same time.On (b)(6) 2022, the set pressure of the valves could not be changed, and x-ray examination confirmed ventricular enlargement.A cerebrospinal fluid drainage is being performed.In he first week of april a revision surgery was performed, one valve was replaced and the patient recovered.The other valve has a poor change in the set pressure, but since no obstruction has been confirmed, it remains implanted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h6, h10.The hakim valve (id 823842) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined; however, the possible root cause for the for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CHPV INLIN/SG INTEGRAL CON
• Common Device Name: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14159779
• Report Number: 3013886523-2022-00170
• Device Sequence Number: 2847687
• Product Code: JXG
• UDI-Device Identifier: 10886704041856
• UDI-Public: 10886704041856
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 82-3842
• Device Catalogue Number: 823842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/22/2022
• 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: 3 YR
• Patient Sex: Female