BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM CATHETER

    MDR report key: 24983838 · Received April 24, 2026

    Report

    Report Number
    3014590708-2026-00012
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 24, 2026
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    NRY
    PMA / PMN Number
    K242672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ZOOM 71 DEVICE WAS DISCARDED AND NOT RETURNED FOR INVESTIGATION. ALTHOUGH THE LOT NUMBER WAS NOT PROVIDED, ALL LOTS SHIPPED TO THE ACCOUNT 6 MONTHS PRIOR TO THE EVENT DATE WERE REVIEWED. THE MANUFACTURING RECORDS CONFIRMED THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS. WITHOUT THE RETURN OF THE DEVICE, THE EXACT ROOT CAUSE FOR THE SHAFT BREAK COULD NOT BE DETERMINED. HOWEVER, BASED ON THE AVAILABLE INFORMATION, SEVERE CALCIFICATION, PROHIBITIVE ANATOMY, AND POSSIBLE OVERTIGHTENING OF THE THIRD-PARTY RHV WERE LIKELY CONTRIBUTING FACTORS. AS MULTIPLE DEVICES WERE INVOLVED IN THE REPORTED EVENT, A RELATED MDR WAS SUBMITTED FOR THE SAME PATIENT AND INCIDENT UNDER REFERENCE NUMBER: 3014590708-2026-00013.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE, TWO ZOOM 71 DEVICES UNRAVELED UPON WITHDRAWAL THROUGH A THIRD-PARTY RHV. THE FIRST ZOOM 71 UNRAVELED AFTER THE INITIAL PASS, AND A SECOND DEVICE SUBSEQUENTLY UNRAVELED FOLLOWING THE SECOND PASS. THE CLOT WAS LOCATED IN THE INTERNAL CAROTID ARTERY (ICA). THE PATIENT PRESENTED WITH A TANDEM OCCLUSION AND SEVERELY CALCIFIED, PROHIBITIVE ANATOMY. THE PATIENT WAS STABLE. THIS COMPLAINT IS BEING SUBMITTED TO REPORT THE FIRST ZOOM 71 DEVICE THAT UNRAVELED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610146 ZOOM CATHETER ZOOM CATHETER NRY IMPERATIVE CARE INC. ICRC071137 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARISTOTLE .024 GUIDEWIRE.| GATEWAY RHV.| ZOOM 35.| ZOOM 71.| ZOOM 88.