BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 20694728 · Received November 15, 2024

    Report

    Report Number
    3013886523-2024-00357
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    October 21, 2024
    Report Date
    March 28, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780518839
    PMA / PMN Number
    K944222
    Adverse Event
    Yes
    Product Problem
    Yes
    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 PERITONEAL CATHETER (ID 823045) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED, IRREGULAR CUTS WERE NOTED AT THE TIP OF CATHETERS. THE CATHETER WAS IRRIGATED; NO OCCLUSION AND NO LEAK NOTED. ROOT CAUSE ANALYSIS - THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO IMPROPER HANDLING OF THE DEVICE IN VIEW OF THE IRREGULAR CUTS THAT WERE NOTED AT THE TIP OF CATHETERS OR COULD BE DUE TO A CONNECTION ISSUE WITH THE VALVE.

    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

    A PHYSICIAN REPORTED A PERITONEAL CATHETER (ID 823045) WAS IMPLANTED DUE TO SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) VIA VENTRICULOPERITONEAL (VP) SHUNT ON SEPTEMBER 23, 2022, WITH SETTING 1. THE PATIENT HAD DEVELOPED VENTRICULAR DILATATION. THE PERITONEAL CATHETER RUPTURED IN THE CONNECTING PART OF THE VALVE, AND IT WAS NOT LIGATED. THE CATHETER HAD FALLEN OF IN THE ABDOMEN. DUE TO THE ISSUE, THE CATHETER WAS REMOVED AND REPLACED ON (B)(6) 2024. THE PATIENT RECOVERED. THE PATIENT PRIMARY DISEASE IS SUBARACHNOID HEMORRHAGE. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY ADDITIONAL SIGNS AND SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56373 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 10381780518839

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention CERTAS VALVE (ID 828804 )