BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM ATRIAL CATH, 46CM

    MDR report key: 20369189 · Received October 4, 2024

    Report

    Report Number
    3013886523-2024-00311
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    September 12, 2024
    Report Date
    March 14, 2025
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780518822
    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

    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 · 0

    THE HAKIM ATRIAL CATHETER (ID 823044) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED; THE RECEIVED CATHETER WAS ONLY 315MM - NO DEFECTS NOTED. THE ENDS OF THE CATHETER WERE VISUALLY INSPECTED AND SEEMED TO BE CLEAN CUT. THE CATHETER WAS IRRIGATED AND LEAK TESTED, NO OCCLUSION AND LEAKS WERE NOTED. THE COMPLAINT WAS UNCONFIRMED. ROOT CAUSE ANALYSIS - NO ROOT CAUSE COULD BE DETERMINED. AS NOTED IN THE INVESTIGATION, NO LEAKAGE WAS NOTED WITH THE RETURNED 315MM CATHETER. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CLEARLY DETERMINED AS ONLY 315MM OF CATHETER WAS RETURNED BUT COULD BE LINKED TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE DEVICE. AS NOTED IN THE IFU, SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM ATRIAL CATHETER WAS IMPLANTED DUE TO UNKNOWN REASON VIA VA (VENTRICULOATRIAL) SHUNT WITH UNKNOWN SETTING IN 2020. THE PATIENT HAD AMBULATION DIFFICULTY. A CONTRAST RADIOGRAPHY WAS PERFORMED AND CONFIRMED A CSF LEAKAGE FROM THE CATHETER; THEREFORE, THE CATHETER WAS EXPLANTED AND REPLACED WITH A NEW ONE ON (B)(6) 2024. HOWEVER, NO LEAK FROM THE CATHETER WAS OBSERVED AFTER IT WAS EXPLANTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721514 HAKIM ATRIAL CATH, 46CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 10381780518822

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention