BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 19876722 · Received July 31, 2024

    Report

    Report Number
    3014590708-2024-00026
    Event Type
    Death
    Date Received
    July 31, 2024
    Date of Event
    June 28, 2024
    Report Date
    July 31, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    PMA / PMN Number
    K211476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THERE WERE NO DEVICE DEFICIENCIES REPORTED RELATED TO THE ZOOM 71. BASED ON THE REPORTED INFORMATION PROVIDED, RESISTANCE WAS ENCOUNTERED IN THE RIGHT CAROTID TERMINUS WHILE ADVANCING THE ZOOM 71. THE PHYSICIAN WAS UNABLE TO ADVANCE THE CATHETER PAST THE POSTERIOR GENU. THE EXACT CAUSE OF THE RESISTANCE AND EXTRAVASATION ARE UNCLEAR. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY.

    Description of Event or Problem · 0

    A 58-YEAR-OLD FEMALE PATIENT PRESENTED WITH TANDEM OCCLUSION, CLOT IN THE INTERNAL CAROTID ARTERY (ICA) AND IN THE M1 SEGMENT. THE PATIENT PRESENTED WITH NORMAL TYPE 1 ARCH WITH NO TORTUOSITY NOTED. ACCESS WAS OBTAINED USING A ZOOM 88 ACCESS CATHETER AND WAS PARKED AT THE HORIZONTAL PETROUS. THE TREATING PHYSICIAN DID NOT EXTEND THE GUIDEWIRE PAST THE TIP OF THE ZOOM 71 AND USING A FLOATING TECHNIQUE, ADVANCED THE ZOOM 71 TO THE M1 SEGMENT. HE HAD DIFFICULTIES DURING ADVANCEMENT AND THE ZOOM 71 WOULD NOT ADVANCE PAST THE POSTERIOR GENU. RESISTANCE WAS FELT NEAR THE CAROTID TERMINUS AS NOTED UNDER FLUOROSCOPY. TO ADVANCE FURTHER, THE PHYSICIAN STOPPED, PULLED BACK THE ZOOM 71 CATHETER TO RELIEVE TENSION. HE INJECTED CONTRAST THROUGH THE ZOOM 71. ANGIOGRAM IMAGING REVEALED EXTRAVASATION AT THE DISTAL SUPRACLINOID INTERNAL ARTERY. AN ATTEMPT WAS MADE TO COIL THE RUPTURE BUT WAS NOT SUCCESSFUL. THE PHYSICIAN ENDED THE PROCEDURE. THE PATIENT EXPIRED THE FOLLOWING DAY. THE CAUSE OF DEATH WAS REPORTED AS EXSANGUINATION. THERE WAS NO DEVICE MALFUNCTION REPORTED AGAINST THE ZOOM DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957437 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2334201

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention| H ARISTOTLE 014 WIRE| ARISTOTLE 024 WIRE| TARGET COILS| ZOOM 71| ZOOM 88