BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGLISS GW, SFT, J 190-014

    MDR report key: 16598035 · Received March 23, 2023

    Report

    Report Number
    3006010712-2023-00014
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    February 2, 2023
    Report Date
    May 16, 2023
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K141831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION REPORT IS ATTACHED TO THIS REPORT.

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.

    Description of Event or Problem · 0

    LAST (B)(6) 2023, AT A CRTD IMPLANT PROCEDURE, THE DR. (B)(6), WHO HAS AN IMPORTANT EXPERIENCE WITH OUR DEVICES, IMPLANTED A GALI 4LV SN: (B)(6). FOR IMPLANT LV LEAD, FIRST OPTION WAS A QUARTET 1458Q-86 WITH SN: (B)(6) AND A HYDROGLISS J SOFT LOT: 5699362 WELL WASHED WITH HEPARINIZED SERUM. THIS GUIDEWIRE HAD VERY PROBLEMS TO PROGRESS INTO THE LEAD AND THE DR. (B)(6) WANTED RETRIEVE IT APPLYING A LOT OF FORCE. AFTER HE USED THE HYDROGLISS J MEDIUM LOT: 5699363 (WELL WASHED WITH HEPARINIZED SERUM) AND HE GOT THE SAME RESULT BUT HE COULD NOT RETRIEVE THE HYDROGLISS. AFTER WE CHANGE THE LV LEAD TO A QUARTET 1456Q-86 SN: (B)(6) AND HE USED THE HYDROGLISS J SOFT LOT: 5699362 AND HE COULD NOT PROGRESS THE GUIDEWIRE CORRECTLY. HE HAD TO APPLY MORE FORCE THAN NORMAL. HE COULD RETRIVE THE GUIDEWIRE APPLYING A LOT OF FORCE AND THE LEAD TWISTED. HE COULD IMPLANT THE LEAD WITH A 0.014" GUIDEWIRE BY ST JUDE WITHOUT PROBLEMS BUT WHEN WE DID THE ELECTRICAL MESUREMENTS WITH THE PSA THE IMPEDANCE WAS <200 OHMS. SO I RECOMMENDED CHAGE THE LV LEAD TO A NEW QUARTET 1458Q-86 SN: (B)(6). IT WAS IMPLANTED WITHOUT PROBLEMS WITH A 0,014" GUIDEWIRE BY ST JUDE MEDICAL.

    Description of Event or Problem · 0

    LAST (B)(6) 2023, AT A CRTD IMPLANT PROCEDURE, THE (B)(6) WHO HAS AN IMPORTANT EXPERIENCE WITH OUR DEVICES, IMPLANTED A GALI 4LV, SN: (B)(4). FOR IMPLANT LV LEAD, FIRST OPTION WAS A QUARTET 1458Q-86 WITH SN: (B)(4) AND A HYDROGLISS J SOFT, LOT: 5699362, WELL WASHED WITH HEPARINIZED SERUM. THIS GUIDEWIRE HAD VERY PROBLEMS TO PROGRESS INTO THE LEAD AND THE (B)(6) WANTED RETRIEVE IT APPLYING A LOT OF FORCE. AFTER HE USED THE HYDROGLISS J MEDIUM, LOT: 5699363, (WELL WASHED WITH HEPARINIZED SERUM) AND HE GOT THE SAME RESULT BUT HE COULD NOT RETRIEVE THE HYDROGLISS (ATTACHED). AFTER WE CHANGE THE LV LEAD TO A QUARTET 1456Q-86 SN: (B)(4) AND HE USED THE HYDROGLISS J SOFT, LOT: 5699362, AND HE COULD NOT PROGRESS THE GUIDEWIRE CORRECTLY. HE HAD TO APPLY MORE FORCE THAN NORMAL. HE COULD RETRIVE THE GUIDEWIRE APPLYING A LOT OF FORCE AND THE LEAD TWISTED. HE COULD IMPLANT THE LEAD WITH A 0.014" GUIDEWIRE BY ST JUDE WITHOUT PROBLEMS BUT WHEN WE DID THE ELECTRICAL MESUREMENTS WITH THE PSA THE IMPEDANCE WAS <200 OHMS. SO I RECOMMENDED CHAGE THE LV LEAD TO A NEW QUARTET 1458Q-86, SN: (B)(4). IT WAS IMPLANTED WITHOUT PROBLEMS WITH A 0,014" GUIDEWIRE BY ST JUDE MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480021 HGLISS GW, SFT, J 190-014 HGLISS GW, SFT, J 190-014 DQX LAKE REGION MEDICAL 901053-04 5699362

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown