BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART PORT CT

    MDR report key: 23692422 · Received December 2, 2025

    Report

    Report Number
    1317056-2025-00337
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    October 14, 2025
    Report Date
    April 29, 2026
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    UDI-DI
    15051684018135
    PMA / PMN Number
    K062414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP 2 EMDR 1317056-2025-00337 WAS SUBMITTED ON 4/24/2026. THE REPORT FAILED DUE TO A DUPLICATE REPORT NUMBER. THE FOLLOW UP REPORT INCORRECTLY DOCUMENTED THE SECTION G6 FOLLOW UP NUMBER AS '1' INSTEAD OF '2.' THIS IS BEING SENT TO CORRECT THAT ERROR. REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECEIVED IN USER FACILITY MEDWATCH; REFERENCE MW5178664. ADDITIONAL INFORMATION ADDED TO THE FOLLOWING SECTIONS: A2; A4; A6; H10. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED THE FOLLOWING ISSUE WITH A CT W/7.5FR DET CATH & VI SMARTPORT: "PATIENT HAD AN ANGIODYNAMICS PORT PLACED BY DR. (B)(6) ON (B)(6). PATIENT ARRIVED AT THE CANCER INSTITUTE ON (B)(6). PORT WAS ACCESSED AND NO BLOOD RETURN NOTED. CATH FLO WAS PLACED AND UNSUCCESSFUL. MD NOTIFIED AND PORTOGRAM WAS ORDERED. COMPLETED ON (B)(6) AND IT SHOWED: DISCONTINUITY OF THE PATIENT'S CENTRAL CATHETER WHICH APPEARS TO HAVE SHEARED AT THE LEVEL OF THE CHEST WALL. THE LOOSE FRAGMENT OF THE CATHETER IS LARGELY WITHIN THE RIGHT ATRIUM. PATIENT WAS THEN SENT TO THE ER AND WAS TRANSFERRED TO GMH TO HAVE THE DEVICE REMOVED FROM RIGHT ATRIUM." DESPITE MULTIPLE GOOD FAITH EFFORT ATTEMPTS, NO FURTHER DETAILS HAVE BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28345 SMART PORT CT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC H787CT75STSDVI1 15051684018135

    Patients

    Seq Age Sex Outcome Treatment
    1