BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM 7X CATHETER

    MDR report key: 23192634 · Received October 1, 2025

    Report

    Report Number
    3014590708-2025-00022
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    August 31, 2025
    Report Date
    October 1, 2025
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    NRY
    PMA / PMN Number
    K243047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 THE REPORTED SHAFT SEPARATION OF THE ZOOM 7X. THE ZOOM 7X WAS RETURNED SEPARATED INTO DISTAL AND PROXIMAL CATHETER SEGMENTS HELD TOGETHER BY THE COIL WHICH MAKES UP PART OF THE INNER CATHETER JACKET. 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 SUPPORT HAD A SINGLE KINK ON THE MID-SHAFT OF THE CATHETER. THE REPORTED COMPLAINT NOTES THAT THE KINK ON THE ZOOM 88 SUPPORT WAS OBSERVED AFTER REMOVAL OF THE DEVICES FROM THE PATIENT. THE FORMATION OF THE KINK ON THE ZOOM 88 SUPPORT MAY HAVE FORMED DUE TO TORTUOUS ANATOMY IN THE FORM OF A CERVICAL KINK IN THE ICA. THE MANUFACTURING RECORDS FOR ZOOM 7X 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 TORTUOUS ANATOMY WITH THE KINK IN THE ZOOM 88 SUPPORT RESULTED IN A RESTRICTION POTENTIALLY LEADING TO THE SHAFT SEPARATION ON THE ZOOM 7X.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A RIGHT M1 MECHANICAL THROMBECTOMY WITH ZOOM 7X, ZOOM SUPPORT AND THIRD-PARTY DEVICES. ACCESS WAS OBTAINED WITH THE ZOOM 88 SUPPORT WHICH WAS PARKED AT THE PETROUS/CAVERNOUS SEGMENT. THE PHYSICIAN INDICATED THE ANATOMY WAS TORTUOUS AND THERE WAS A CERVICAL KINK IN THE INTERNAL CAROTID ARTERY (ICA). SOME RESISTANCE WAS NOTED AND AFTER FIRST PASS, THE PHYSICIAN PULLED THE DEVICES AS A SYSTEM OUT OF THE BODY. A KINK WAS OBSERVED ON THE ZOOM 88 SUPPORT AND THE ZOOM 7X WAS STRETCHED AND ALMOST FRACTURED. THE PHYSICIAN PROCEEDED WITH ANOTHER THIRD-PARTY DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO ADDITIONAL INTERVENTION PERFORMED, AND NO PATIENT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106872 ZOOM 7X CATHETER ZOOM 7X CATHETER NRY IMPERATIVE CARE INC. ICRC07X137 F2513503

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Female BALT CARRIER| COLOSSUS GUIDE WIRE| GLIDEWIRE ADVANTAGE| NEURON MAX ACCESS CATHETER| RED 72 WITH SENDIT CATHETER SYSTEM