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

Catalog Number	823162
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Headache (1880); Lethargy (2560)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id (b)(6)) was implanted on (b)(6) 2024 with setting 190mmh20 and the procedure performed was ventricular pleural shunt.The patient experienced issues with overdrainage to underdrainage and computed tomography (ct) scan confirmed it.The patient experienced headaches and lethargic neurologic changes.The valve was severed from siphonguard.Therefore, it was removed on (b)(6) 2024 and placed with external ventricular drainage (evd).
Additional Manufacturer Narrative
The hakim valve (id (b)(6)) was not returned for evaluation (as per customer, product not available) 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, a probable root cause for the reported complaint could be due to a sharp or pointed object or a knock to the valve.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: 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 ; 6099362319
• MDR Report Key: 18966532
• Report Number: 3013886523-2024-00093
• Device Sequence Number: 15095921
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: 10381780519232
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2024

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
• Device Lot Number: 7126841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2024
• 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