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

Catalog Number	823110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Headache (1880)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id 823110) was implanted in 2016 due to snph (secondary normal pressure hydrocephalus) via a ventriculoperitoneal (v-p) shunt set at 50 mmh2o.On (b)(6) 2025, the patient experienced a headache and visited the hospital.An x-ray confirmed that the peritoneal catheter had ruptured around the neck.Therefore, the device was removed and replaced on (b)(6) 2025.The doctor assumed that the catheter had been under tensile force, which caused the rupture.The patient recovered.
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 823110) was returned for evaluation.Device history record (dhr) - the product code 82-3110 with lot cvfbw0, conformed to the specifications when released to stock.Failure and root cause analysis - the catheter was visually inspected; the end of the catheter has a regular cut.This issue is due to a sharp or pointed object coming into contact with the catheter.As noted in the surgical procedure precautions section in instruction for use (ifu): silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE CLYNDRICAL W PRECHA
• Common Device Name: CHPV
• 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: 22202942
• Report Number: 3013886523-2025-00144
• Device Sequence Number: 6746579
• Product Code: JXG
• UDI-Device Identifier: 10886704041450
• UDI-Public: (01)10886704041450(17)210331(10)CVFBW0
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 08/21/2025

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 Expiration Date: 03/31/2021
• Device Catalogue Number: 823110
• Device Lot Number: CVFBW0
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2016
• 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: PERITONEAL CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male