BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 11023335 · Received December 16, 2020

    Report

    Report Number
    3014590708-2020-00008
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 13, 2020
    Report Date
    December 16, 2020
    Manufacturer
    IMPERATIVE CARE INC
    Product Code
    NRY
    UDI-DI
    00812212030061
    PMA / PMN Number
    K202182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR RETURN BUT HAS NOT YET RETURNED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY. APPROPRIATE TESTING AND INSPECTION WAS COMPLETED TO ENSURE THE DEVICE MET MINIMUM TENSILE SPECIFICATION AND IS KINK RESISTANT. THE MID SHAFT SECTION UNDERGOES 100% VISUAL INSPECTION AND IS FREE OF VISUAL DEFECTS OR KINKS. AT THIS TIME, THE CAUSE OF THE BREAK IS UNKNOWN.

    Description of Event or Problem · 1

    A THROMBECTOMY WAS PERFORMED TO TREAT OCCLUSION IN THE RIGHT SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE ACCESS CATHETER WAS DELIVERED OVER AN INTERMEDIATE CATHETER AND 035 GUIDEWIRE TO ACCESS THE RIGHT COMMON CAROTID. IMAGING DEMONSTRATED AN EXTREMELY TORTUOUS TAKEOFF FROM THE AORTIC ARCH. AFTER TWO INITIAL PASSES WITH A ZOOM 71 REPERFUSION CATHETER, THE PHYSICIAN NOTED KINK AT TWO LOCATIONS WITHIN THE ACCESS CATHETER - ONE IN THE DISTAL SEGMENT AND ANOTHER IN THE MID SHAFT. ZOOM 71 REPERFUSION CATHETER ENCOUNTERED RESISTANCE WHICH PROMPTED THE REMOVAL OF THE ZOOM 71 FOR A NEW ZOOM 71. AFTER THE FIRST PASS WITH THE NEW ZOOM 71, HE ENCOUNTERED SIGNIFICANT RESISTANCE WHEN PULLING BACK. THE OUTER SHAFT ENDED UP BREAKING WITHIN THE PATIENT WITHOUT SEPARATING. THE PHYSICIAN PROCEEDED TO REMOVE THE ACCESS CATHETER AND ZOOM 71 REPERFUSION CATHETER AS ONE UNIT, AND WAS ABLE TO REMOVE THE ZOOM 71 REPERFUSION CATHETER FROM THE ACCESS CATHETER AFTER STRAIGHTENING THE KINK. THERE WAS NO ADVERSE EVENT OR NEGATIVE PATIENT OUTCOME. THE PATIENT IS DOING FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484063 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE INC ICRC071137 F2003401 00812212030061

    Patients

    Seq Age Sex Outcome Treatment
    1