BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM 7X CATHETER

    MDR report key: 23846548 · Received December 18, 2025

    Report

    Report Number
    3014590708-2025-00029
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 18, 2025
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    NRY
    PMA / PMN Number
    K243047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A ZOOM 7X AND A ZOOM 88 SUPPORT WERE RETURNED FOR INVESTIGATION. INVESTIGATION CONFIRMED SHAFT SEPARATION OF THE ZOOM 7X. THE ZOOM 7X WAS RETURNED SEPARATED INTO DISTAL AND PROXIMAL CATHETER SEGMENTS. DEVICE INVESTIGATION NOTED DAMAGE TO THE ZOOM 7X CATHETER SHAFT WHICH SUGGESTS AN AXIAL FORCE WAS APPLIED DURING THE PROCEDURE RESULTING IN STRETCHING OF SHAFT MATERIALS PRIOR TO THE DEVICE BREAKING. EVIDENCE OF STRETCHED CATHETER JACKET MATERIALS WAS OBSERVED ON EACH CATHETER SEGMENT. THE ZOOM 88 SUPPORT HAD A SINGLE KINK ON THE MID-SHAFT OF THE CATHETER. THE LOT NUMBER OF THE ZOOM 7X SHIPPED TO THE CUSTOMER WAS UNKNOWN. A REVIEW OF MANUFACTURING RECORDS FOR LOTS SHIPPED TO THE ACCOUNT 6 MONTHS PRIOR TO THE INCIDENT WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS. BASED ON THE COMPLAINT INFORMATION PROVIDED, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY THAT THE REPORTED TORTUOUS ARCH AND THE KINK IN THE ZOOM 88 SUPPORT RESULTED IN A RESTRICTION WITHIN THE SUPPORT CATHETER POTENTIALLY LEADING TO RESISTANCE AND SHAFT SEPARATION DURING RETRACTION OF THE ZOOM 7X.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A MECHANICAL THROMBECTOMY FOR A LEFT CAROTID TERMINUS OCCLUSION WITH A ZOOM 7X, ZOOM 88 SUPPORT AND THIRD-PARTY DEVICES. DURING ADVANCEMENT AND RETRACTION OF ZOOM 88 SUPPORT, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN NOTED A LARGE CLOT BURDEN AND A TIGHT POSTERIOR GENU, WHICH LIKELY CONTRIBUTED TO THE RESISTANCE. RESISTANCE WAS ALSO OBSERVED DURING RETRACTION OF THE ZOOM 7X. AFTER THE FIRST PASS, IT WAS NOTED THAT THE ZOOM 7X UNRAVELED AND FRACTURED. THE PHYSICIAN THEN REMOVED THE ZOOM 7X AND THE ZOOM 88 SUPPORT AND USED A ZOOM 88 ALONG WITH A NEW ZOOM 7X TO RETRIEVE THE DISTAL SEGMENT OF THE ZOOM 7X. THE REMAINDER OF THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND TICI 3 FLOW WAS ACHIEVED. THE PATIENT REMAINED STABLE POST-PROCEDURE. ADDITIONALLY, UPON COMPLETION OF THE PROCEDURE, THE PHYSICIAN OBSERVED A KINK ON THE SHAFT OF THE ZOOM 88 SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257281 ZOOM 7X CATHETER ZOOM 7X CATHETER NRY IMPERATIVE CARE INC. ICRC07X137 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention ARISTOTLE 24| RED 43| ZOOM 88| ZOOM DUOPORT| ZOOM SUPPORT