BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM 7X CATHETER

    MDR report key: 23009899 · Received September 9, 2025

    Report

    Report Number
    3014590708-2025-00020
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 17, 2025
    Report Date
    September 9, 2025
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    NRY
    UDI-DI
    00812212030757
    PMA / PMN Number
    K243047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTAL SEGMENT OF THE ZOOM 7X CATHETER SHAFT WAS NOT RETURNED FOR INVESTIGATION. THE ZOOM 7X PROXIMAL SEGMENT WAS RETURNED AND DEVICE INVESTIGATION CONFIRMED SHAFT BREAKAGE AND SUGGESTED THAT AN AXIAL FORCE WAS APPLIED DURING THE PROCEDURE RESULTING IN SEPARATION OF THE DISTAL SEGMENT. KINK DAMAGE WAS OBSERVED ON THE PROXIMAL END OF THE RETURNED DEVICE. THE MANUFACTURING RECORDS FOR THE ZOOM 71 WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS. WITHOUT RETURN OF THE RHV (UNKNOWN MAKE/MODEL), THE EXACT ROOT CAUSE FOR THE SHAFT BREAK COULD NOT BE DETERMINED FROM THE DEVICE INVESTIGATION. LIMITED CASE INFORMATION INDICATED THAT THE ZOOM 7X HAD BECOME STUCK IN THE RHV DURING REMOVAL RESULTING IN THE CATHETER BREAK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A LEFT M1 MECHANICAL THROMBECTOMY WITH ZOOM 7X, A THIRD-PARTY GUIDEWIRE AND ACCESS CATHETER USING DUAL ASPIRATION. DURING REMOVAL OF THE ZOOM 7X THROUGH THE RHV, THE DISTAL PORTION OF THE ZOOM 7X CATHETER BECAME STUCK AND SEPARATED. THE PHYSICIAN REMOVED THE RHV TO RETRIEVE THE DISTAL SEGMENT OF THE ZOOM 7X. NO FURTHER INTERVENTION WAS REQUIRED, AS THE PROCEDURE WAS SUCCESSFULLY COMPLETED IN A SINGLE PASS. THERE WAS NO PATIENT SEQUELEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2825627 ZOOM 7X CATHETER ZOOM 7X CATHETER NRY IMPERATIVE CARE INC. ICRC07X137 F2516701 00812212030757

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARISTOTLE 24| BALLAST SHEATH| ZOOM DUOPORT| ZOOM PODS