BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM¿ 88 LARGE DISTAL PLATFORM

    MDR report key: 14877126 · Received June 30, 2022

    Report

    Report Number
    3014590708-2022-00013
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    May 30, 2022
    Report Date
    June 30, 2022
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    QJP
    UDI-DI
    00812212030368
    PMA / PMN Number
    K212224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AFTER USE AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY. ALL DEVICES UNDERGO TESTING AND INSPECTION CONFIRMING DEVICES MEET SPECIFICATIONS PRIOR TO RELEASE. BASED ON THE INFORMATION PROVIDED, A CAROTID CAVERNOUS FISTULA (CCF) OCCURRED DURING THE RECANALIZATION PROCEDURE IN THE CAVERNOUS REGION WHERE THERE WERE ANEURYSMS AND ATHEROSCLEROSIS. PER THE PROCEDURE NOTE, THERE WAS NO EVIDENCE OF CATHETER PERFORATION THROUGH THE VESSEL OR ANY MENTION OF CATHETERS TRACKING IN AN UNEXPECTED FASHION TO RESULT IN A VESSEL PERFORATION. THERE WAS NO TREATMENT OF THE CCF PERFORMED. PER THE PHYSICIAN, THE PROCEDURE WAS WELL-TOLERATED BY THE PATIENT. THERE WERE NO DEVICE ISSUES REPORTED RELATED THE ZOOM 88 DEVICE. THE INSTRUCTION FOR USE WARNS USER THAT "EXTREME CAUTION SHOULD BE USED IF IT IS REQUIRED THAT THE ZOOM 88 BE ADVANCED NEAR OR THROUGH ANY ANEURYSMS OR OTHER VASCULAR MALFORMATIONS".

    Description of Event or Problem · 0

    A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION, EXTENSIVE CEREBROVASCULAR DISEASE WAS BEING TREATED FOR A CAROTID TERMINUS OCCLUSION WITH THE CLOT IN THE INTERNAL CAROTID ARTERY (ICA) TERMINUS. WHEN ADVANCING THE ZOOM 88 CATHETER PAST AN ANEURYSM THAT WAS NOT INITIALLY VISUALIZED, A PERFORATION OF THE ANEURYSM OCCURRED CREATING A CAVERNOUS CAROTID FISTULA (CCF). THERE WAS NO TREATMENT PERFORMED FOR THE CCF. THE TERMINUS CLOT WAS SUCCESSFULLY REMOVED, AND VESSEL PERFUSION RESTORED. PER THE CASE NOTES PROVIDE BY THE PHYSICIAN, RIGHT FEMORAL ARTERY WAS PERCUTANEOUSLY ACCESSED WITH A 4F MICROPUNCTURE SET AND A SHORT 8F SHEATH WAS THEN PLACED. 5F DIAGNOSTIC CATHETER WAS ADVANCED OVER AN ANGLED GUIDEWIRE INTO THE AORTIC ARCH FOR THE INITIAL ANGIOGRAM. IMAGING SHOWED EXTENSIVE INTRACRANIAL AND EXTRA CRANIAL ATHEROSCLEROTIC DISEASE AND EXTENSIVE PLAQUE THROUGHOUT THE CAROTID BULB WITH A HIGH-GRADE STENOSIS AT THE LEFT COMMON CAROTID ARTERY AND CERVICAL INTERNAL CAROTID. DIAGNOSTIC CATHETER WAS THEN EXCHANGED FOR A ZOOM 88 OVER GUIDEWIRE WHICH WAS ADVANCED INTO THE DISTAL CERVICAL LEFT ICA. A ZOOM 71 WAS THEN ADVANCED OVER A 0.16" GUIDEWIRE, AND ADVANCED JUST BEYOND THE CLOT UNDER SUCTION, WITH THE ZOOM 88 ALSO ADVANCED TO THE CAVERNOUS SUPRACLINOID JUNCTION AT ABOUT THE LEVEL OF THE OCCLUSION. ASPIRATION THROMBECTOMY WAS STARTED AND CONTINUED FOR APPROXIMATELY 1 MIN. ZOOM 71 WAS REMOVED AND FOLLOW-UP ANGIOGRAM OBTAINED THROUGH THE INDWELLING GUIDE SHEATH SHOWED RECANALIZATION OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA) AND SHUNTING OF BLOOD INTO THE CAVERNOUS SINUSES DUE TO A PERFORATION. SEVERAL LEFT ICA IMAGES SHOWED FILLING OF NEARLY ALL MCA AND LEFT A1 SEGMENT WAS PATENT. THERE WAS A RESIDUAL CLOT WITHIN THE MID TO DISTAL A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). NO FURTHER THROMBECTOMY WAS ATTEMPTED DUE TO THE PRESENCE OF THE CAROTID RENT CCF AS WELL AS THE DISTAL LOCATION OF THE RESIDUAL ACA CLOT. FINAL TICI2B WAS ACHIEVED. A RESIDUAL CCF WAS OBSERVED AT THE COMPLETION OF THE PROCEDURE. THERE WAS NO EVIDENCE OF ANY INTRACRANIAL EXTRAVASATION. THERE WAS NO TREATMENT OF THE CCF. PER THE CASE NOTES PROVIDED BY THE PHYSICIAN, THE PROCEDURE WAS WELL-TOLERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057974 ZOOM¿ 88 LARGE DISTAL PLATFORM GUIDE CATHETER QJP IMPERATIVE CARE. INC ICTC088110 00812212030368

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other 5FR DIAGNOSTIC CATHETER| FATHOM 16 GUIDEWIRE| ROSEN WIRE| ZOOM 71