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

Catalog Number	823832
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 1 of 2 reports linked to mfg report number: 3013886523-2025-00298.A facility reported a hakim valve (id 823832) and a codman bactiseal catheter (id 823072) were implanted on august 13, and the procedure proceeded without complications.On (b)(6) the patient developed a mild fever; therefore, a postoperative exploration was performed, which revealed tube obstruction.The shunt and catheter were removed but not replaced, and anti-infection treatment was administered.The patient subsequently recovered well.
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823832) was returned for evaluation.Device history record (dhr) - the product code 82-3832 with lot 7302947 conformed to specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at setting 60 mmh2o.The valve was visually inspected, biologicals debris observed in the casing.The valve passed the test for occlusion, leak, reflux and siphon guard.The valve failed the test for programming.The valve could not be pressure tested as the cam was blocked at 60mmh2o.The valve was dismantled and examined under microscope at appropriate magnification: biological debris were noted on the plate, ball seat, motor and the ball.The cam magnets were controlled and passed the test.Root cause analysis - the root cause for the programming issue observed during investigation and reported issue (obstruction) is due to biologicals debris.The probable root cause for the "infection" issue reported by the customer could be linked to the patient and hospital surroundings.
Event or Problem Description
N/a.

• 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: 23435930
• Report Number: 3013886523-2025-00297
• Device Sequence Number: 17332961
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)281031(10)7302947
• Combination Product (Y/N): Y
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/25/2025

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: 823832
• Device Lot Number: 7302947
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BACTISEAL CATHETER (ID 823072)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian