BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM CATHETER

    MDR report key: 23857421 · Received December 19, 2025

    Report

    Report Number
    3014590708-2025-00033
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 19, 2025
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    NRY
    UDI-DI
    00812212030498
    PMA / PMN Number
    K242672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ZOOM 45 WAS DISCARDED AND NOT RETURNED FOR INVESTIGATION. THE MANUFACTURING RECORDS WERE REVIEWED AND SHOWED THE PRODUCT MET DESIGN AND MANUFACTURING SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED, IT IS UNCLEAR IF THE DISSECTION WAS CAUSED BY ZOOM 45, ZOOM 7X OR THIRD-PARTY DEVICES. THERE WAS NO DEVICE ISSUES REPORTED FOR ANY OF THE ZOOM DEVICES USED DURING THE CASE. AS MULTIPLE DEVICES WERE INVOLVED IN THE REPORTED EVENT, A RELATED MDR WAS SUBMITTED FOR THE SAME PATIENT AND INCIDENT UNDER REFERENCE NUMBER 3014590708-2025-00032.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY FOR AN ACUTE ISCHEMIC STROKE INVOLVING THE LEFT M1/M2 ARTERIES. THE PHYSICIAN UTILIZED A THIRD-PARTY MEDIUM CARRIER DELIVERY CATHETER ALONG WITH ZOOM 7X TO ACCESS THE CLOT LOCATED IN THE DISTAL M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). ZOOM 7X WAS POSITIONED IN THE DISTAL M1 AT THE BIFURCATION OF THE SUPERIOR & INFERIOR BRANCHES. AFTER THE FIRST PASS WITH ZOOM 7X, THE INFERIOR DIVISION WAS PATENT, WHILE THE SUPERIOR DIVISION REMAINED OCCLUDED. THE PHYSICIAN THEN ADVANCED A ZOOM 45 INTO THE SUPERIOR BRANCH BUT WAS UNABLE TO ADVANCE FAR ENOUGH, SO DEPLOYED A THIRD-PARTY STENT RETRIEVER ACROSS THE OCCLUSION, FOLLOWED BY ZOOM 45, AND A SECOND PASS WAS PERFORMED. SOME IMPROVEMENT WAS NOTED IN THE M2 SUPERIOR BRANCH; HOWEVER, FLOW BECAME STAGNANT IN THE INFERIOR BRANCH. AT THIS POINT, A DISSECTION WAS OBSERVED AT THE M1 BIFURCATION OF THE SUPERIOR AND INFERIOR BRANCHES OF THE LEFT MCA, WHICH THE PHYSICIAN ATTRIBUTED AS LIKELY RESULTING FROM ZOOM 7X. THE DISSECTION BECAME PROMINENT AS THE PROCEDURE PROGRESSED; ADDITIONAL PASSES WERE ATTEMPTED WITH A ZOOM 45 AND A ZOOM 35 IN THE INFERIOR BRANCH RESULTING IN TEMPORARY RECANALIZATION; HOWEVER SUBSEQUENT ANGIOGRAMS REVEALED RECURRENT STAGNANT FLOW. TO ADDRESS THE DISSECTION, THE PHYSICIAN PLACED A STENT, WHICH INITIALLY RESTORED FLOW BUT SUBSEQUENTLY OCCLUDED DUE TO INSUFFICIENT RADIAL FORCE AND/OR THROMBOTIC ACTIVITY. THROMBOGENIC ACTIVITY WAS NOTED PROXIMAL TO THE DISSECTION SITE, AND THE PHYSICIAN SUSPECTED THIS CONTRIBUTED TO INCONSISTENT PERFUSION. AN ADDITIONAL PASS WAS PERFORMED WITH THE ZOOM 7X IN THE MID/DISTAL M1 SEGMENT TO MANAGE THE NEWLY FORMED THROMBUS. THE OUTCOME WAS TICI 2A WITH NO IMPROVEMENT FROM THE INITIAL PRESENTATION. THE PATIENT WAS STABLE POST PROCEDURE AND WAS DISCHARGED TO NEURO INTENSIVE CARE UNIT (ICU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534294 ZOOM CATHETER ZOOM CATHETER NRY IMPERATIVE CARE INC. ICRC045144 F2424102 00812212030498

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention BALT CARRIER DELIVERY CATHETER (MEDIUM)| INFINITY PLUS GUIDE CATHETER (STRYKER)| NEUROFORM ATLAS STENT (3X15)| PHENOM MICROCATHETER| SOLITAIRE STENT RETRIEVER (4 MM)| SYNCHRO GUIDEWIRE| ZOOM 35 CATHETER| ZOOM 7X CATHETER