BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM RDL RADIAL ACCESS SYSTEM

    MDR report key: 19743044 · Received July 15, 2024

    Report

    Report Number
    3014590708-2024-00025
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 15, 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 FEMALE PATIENT WAS ADMITTED FOR A BILATERAL MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION PROCEDURE. ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY USING A ZOOM 88 SUPPORT GUIDE CATHETER. THE RIGHT-SIDE EMBOLIZATION WAS COMPLETED SUCCESSFULLY WITH NO ISSUES. HOWEVER, WHILE ATTEMPTING TO TRACK THE CATHETER THROUGH THE AORTIC ARCH OVER TO THE LEFT COMMON CAROTID ARTERY, SIGNIFICANT RESISTANCE WAS FELT. THE ZOOM 88 SUPPORT GUIDE CATHETER WAS REMOVED, AND A ZOOM RDL WAS INTRODUCED USING THE RDL DILATOR OVER 0.035" GLIDEWIRE ADVANTAGE AND A NON-DISCLOSED THIRD PARTY SELECT CATHETER. UPON ATTEMPTING TO ADVANCE THE ZOOM RDL INTO THE ARCH ANATOMY, RESISTANCE WAS AGAIN FELT. THE TREATING PHYSICIAN ATTEMPTED TO REMOVE THE RDL BUT WAS UNSUCCESSFUL. IT WAS CONFIRMED THAT VASOSPASM OCCURRED, AND THE RADIAL ARTERY CLAMPED DOWN ON THE SHAFT OF THE RDL AT APPROXIMATELY 3-4 CM FROM THE RADIAL ACCESS SITE. VASODILATOR MEDICATIONS WERE ADMINISTERED AT THE BEGINNING OF THE CASE AS WELL AS TO RELIEVE THE VASOSPASM. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO REMOVE THE CATHETER, THE TREATING PHYSICIAN CALLED IN FOR SURGICAL SUPPORT. MEANWHILE, THE PHYSICIAN USED FEMORAL ACCESS AND SUCCESSFULLY COMPLETED THE LEFT MMA EMBOLIZATION PROCEDURE WITHOUT ANY ISSUES. IMMEDIATELY FOLLOWING THE MMA EMBOLIZATION AND WHILE STILL IN THE ANGIO SUITE, THE ORTHOPEDIC SURGERY TEAM SUCCESSFULLY REMOVED THE CATHETER AND REPAIRED THE ARTERY. THE PATIENT WAS RELEASED THE NEXT DAY WITH A FULL RECOVERY FROM BOTH THE RADIAL INJURY AND A SUCCESSFUL MMA EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459298 ZOOM RDL RADIAL ACCESS SYSTEM GUIDE CATHETER DQY IMPERATIVE CARE INC. ICTC088103R F2402202 00812212030566

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention GLIDEWIRE ADVANTAGE| SIM 2 SELECT CATHETER| ZOOM 88 SUPPORT