BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM RDL RADIAL ACCESS SYSTEM

    MDR report key: 20173509 · Received September 9, 2024

    Report

    Report Number
    3014590708-2024-00032
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    August 14, 2024
    Report Date
    September 9, 2024
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    DQY
    UDI-DI
    00812212030566
    PMA / PMN Number
    K220807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AFTER USE AND THEREFORE NOT AVAILABLE FOR RETURN. BASED ON THE REPORTED INFORMATION PROVIDE, THE PATIENT EXPERIENCED VASOSPASM DURING RETRACTION OF THE ZOOM RDL AND WAS ADMINISTERED VASODILATOR DRUGS. IT IS UNCLEAR WHAT MAY HAVE CONTRIBUTED TO THE POTENTIAL ABNORMAL INTERACTION WITH THE DEVICE AND RADIAL ARTERY. THE MANUFACTURING RECORDS FOR THE ZOOM DEVICE WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 0

    A 73-YEAR-OLD FEMALE PATIENT WAS ADMITTED FOR A BILATERAL MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION PROCEDURE. ACCESS WAS OBTAINED VIA RIGHT RADIAL ARTERY USING A ZOOM RDL AS A GUIDE CATHETER. THE RDL CATHETER WAS NAVIGATED SMOOTHLY TO THE RIGHT EXTERNAL CAROTID ARTERY WITHOUT ISSUE. AFTER SUCCESSFULLY TREATING THE RIGHT SIDE, THE RDL CATHETER WAS RETRACTED AND ADVANCED ACROSS THE AORTIC ARCH TO THE LEFT COMMON CAROTID AND THEN UP TO THE LEFT EXTERNAL CAROTID. DURING THIS ADVANCEMENT, RESISTANCE WAS FELT; HOWEVER, THE OPERATORS WERE NOT CONCERNED ABOUT VASOSPASM. SUCCESSFUL TREATMENT OF THE LEFT MMA WAS ACCOMPLISHED WITHOUT ANY ISSUES. UPON COMPLETION AND FINAL ANGIOGRAPHY, THE PHYSICIAN ATTEMPTED TO REMOVE THE RDL. THE CATHETER WAS RETRACTED UNTIL THE DISTAL TIP OF THE RDL WAS SEVERAL CENTIMETERS ABOVE THE RIGHT ELBOW. HOWEVER, IT COULD NOT BE REMOVED. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE RDL WITHOUT DAMAGING THE ARTERY, INCLUDING ADMINISTERING MORE VASODILATORS (VERAPAMIL), USING A BLOOD PRESSURE CUFF, AND A TRANSPARENT RADIAL ARTERY BAND; BUT THE RDL WOULD NOT RELEASE. THE PATIENT WAS TRANSPORTED TO SURGERY FOR REMOVAL OF THE RDL. THE ORTHOPEDIC SURGERY TEAM SUCCESSFULLY REMOVED THE CATHETER AND REPAIRED THE ARTERY. THE PATIENT HAS FULLY RECOVERED FROM THE RADIAL INJURY AND WAS REPORTED TO BE STABLE. NO DEVICE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538683 ZOOM RDL RADIAL ACCESS SYSTEM GUIDE CATHETER DQY IMPERATIVE CARE INC. ICTC088103R F2412201 00812212030566

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention 0.035" GLIDEWIRE| 0.038" GLIDEWIRE| APOLLO MICRO-CATHETERS| HYBRID WIRES| ZOOM 45| ZOOM 6F SIM INSERT CATHETER