BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 19639452 · Received June 28, 2024

    Report

    Report Number
    3014590708-2024-00020
    Event Type
    Death
    Date Received
    June 28, 2024
    Date of Event
    February 11, 2024
    Report Date
    June 28, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030498
    PMA / PMN Number
    K210996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE DISCARDED AFTER USE AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION. THERE WERE NO DEVICE DEFICIENCIES REPORTED RELATED TO THE ZOOM 45. BASED ON THE LIMITED CASE IMAGE AND INFORMATION PROVIDED, THE EXACT CAUSE OF THE VESSEL PERFORATION IS UNKNOWN. THE RELATIONSHIP WITH THE ZOOM DEVICE TO THE VESSEL PERFORATION COULD NOT BE ESTABLISHED. IT IS UNCLEAR IF THE PERFORATION WAS CAUSED BY THE ZOOM DEVICE OR OTHER DEVICES. THE MANUFACTURING RECORDS FOR THE ZOOM 45 DEVICE WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 0

    DURING AN IN-SERVICE VISIT, THE PHYSICIAN REPORTED TO THE IMPERATIVE CARE SALES REPRESENTATIVE ABOUT A VESSEL PERFORATION EVENT THAT OCCURRED "A FEW MONTHS AGO" WITH A ZOOM 45 CATHETER. THE CLOT LOCATION WAS IN THE INFERIOR DISTAL M2 SEGMENT. DURING THE FIRST PASS, THE PHYSICIAN USED A THIRD-PARTY ACCESS CATHETER AND TWO DIFFERENT SIZE ASPIRATION CATHETERS OVER A GUIDEWIRE, BUT THEY COULD NOT ADVANCE. BOTH ASPIRATION CATHETERS WERE REMOVED FROM THE PATIENT. WITH THE SAME THIRD-PARTY ACCESS CATHETER IN PLACE, THE PHYSICIAN THEN ADVANCED A ZOOM 45 CATHETER OVER A THIRD-PARTY MICROCATHETER AND GUIDEWIRE TO THE FACE OF THE CLOT IN THE M2 SEGMENT. THE MICROCATHETER AND GUIDEWIRE WERE THEN REMOVED FROM THE PATIENT. ASPIRATION WAS APPLIED TO THE ZOOM 45. THE PHYSICIAN DOES NOT KNOW IF THE CLOT WAS REMOVED. POST-ASPIRATION IMAGING REVEALED A VESSEL PERFORATION OF THE DISTAL M2 SEGMENT. THE PATIENT BECAME UNSTABLE, AND THE PHYSICIAN ENDED THE PROCEDURE. THERE WAS NO TREATMENT ADMINISTERED. THE PHYSICIAN INDICATED THAT THE PATIENT WAS ELDERLY AND HAD TORTUOUS ANATOMY WITH FRAGILE VESSELS. THE PHYSICIAN WAS NOT SURE IF THE ZOOM 45 HAD CAUSED THE VESSEL PERFORATION. NO DEVICE DEFICIENCY WAS REPORTED. THE PATIENT PASSED AWAY DUE TO CARDIAC ARREST AT AN UNKNOWN TIME ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828273 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC045144 F2326202 00812212030498

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Life Threatening ARISTOTLE 24 GUIDEWIRE| PHENOM 27 MICROCATHETER| RED 43| RED 62