BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE CLYNDRICAL W PRECHA

    MDR report key: 22202942 · Received June 13, 2025

    Report

    Report Number
    3013886523-2025-00144
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    May 22, 2025
    Report Date
    August 21, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041450
    PMA / PMN Number
    K221840
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343064 PROG VALVE CLYNDRICAL W PRECHA CHPV JXG INTEGRA LIFESCIENCES MANSFIELD CVFBW0 10886704041450

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention PERITONEAL CATHETER.