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

Catalog Number	823842
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2024
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 physician reported a hakim valve (id 823162) was implanted due to secondary normal pressure hydrocephalus (snph) via ventriculoperitoneal (vp) shunt on unknown date with unknown setting.The distal part of the valve had ruptured however, it was not punctured.Therefore, the valve was removed and replaced on (b)(6) 2024 due to suspicion of obstruction.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823162) was returned for evaluation.Device history record (dhr): the product code 823842 with lot cjmbnn, sn (b)(6), conformed to the specifications when released to stock.Failure analysis: the position of the cam when valve was received was on setting 170 mmh2o.The valve was visually inspected, the silicone housing around the siphon guard was cut/torn.The ventricular connector was broken.The valve failed the test for programming.The valve could not be flushed, leak and reflux as the siphon guard was broken and the needle guard was missing.The pressure test could not be performed because the device cannot be programmed and the needle guard missing.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the spring, on the rotating construct, and on the arm assembly.Root cause analysis: the root cause for cut/tear in the silicone housing could be due to a sharp or pointed object coming into contact with the silicone housing, as noted in the ifu silicone has a low cut/tear resistance.The root cause for the programming issue is due to biological debris and protein build up interfering with the device.The root cause for the issue reported by the customer is due to biological debris and protein build up interfering with the device.
Event or Problem Description
N/a.

• Brand Name: CHPV INLIN/SG INTEGRAL CON
• 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: 20081300
• Report Number: 3013886523-2024-00260
• Device Sequence Number: 15343941
• Product Code: JXG
• UDI-Device Identifier: 10381780535065
• UDI-Public: 10381780535065
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2013
• Device Catalogue Number: 823842
• Device Lot Number: CJMBNN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male