BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 20070918 · Received August 26, 2024

    Report

    Report Number
    3014590708-2024-00029
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 26, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030450
    PMA / PMN Number
    K211476
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROXIMAL SEGMENT OF THE ZOOM 71 CATHETER WAS RETURNED FOR INVESTIGATION. INVESTIGATION CONFIRMED THAT SHAFT BREAKAGE THAT OCCURRED AND SUGGESTED THAT AN AXIAL FORCE WAS APPLIED DURING THE PROCEDURE, STRETCHING THE SHAFT MATERIALS PRIOR TO BREAKING. BASED ON THE COMPLAINT INVESTIGATION, LIMITED CASE IMAGES AND NO RETURN OF ADJUNCTIVE DEVICE, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE EVENT DESCRIPTION, EVIDENCE SUGGESTS THAT A TORTUOUS ANATOMY AND RETRACTION OF THE ZOOM 71 AGAINST RESISTANCE WERE POTENTIAL FACTORS THAT CONTRIBUTED TO THE REPORTED SHAFT BREAK. THE MANUFACTURING RECORDS FOR THE ZOOM 71 WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 0

    AN 85-YEAR-OLD PATIENT WAS TREATED FOR AN OCCLUSION AT THE LEFT MIDDLE CEREBRAL ARTERY (MCA). ACCESS WAS OBTAINED USING A ZOOM 88 ACCESS CATHETER, WHICH WAS ADVANCED TO THE HIGH CERVICAL. THE PHYSICIAN NOTED A KINK IN THE ACCESS CATHETER, DUE TO A 360-DEGREE LOOP AT THE ILIAC. THE PHYSICIAN STRAIGHTENED OUT THE KINK. DURING THE FIRST PASS, A ZOOM 71 ASPIRATION CATHETER WAS ADVANCED THROUGH THE ZOOM 88 TO THE CLOT IN THE LEFT MCA. THE PHYSICIAN CONFIRMED THERE WAS NO RESISTANCE WHILE ADVANCING THE CATHETER. AFTER THE ZOOM 71 CORKED THE CLOT, ASPIRATION WAS APPLIED, AND THE CLOT WAS REMOVED AFTER THE FIRST PASS. THE PATIENT ACHIEVED COMPLETE REPERFUSION WITH A TICI 3 SCORE. WHILE RETRACTING THE ZOOM 71 THROUGH THE ZOOM 88, RESISTANCE WAS NOTED. THE PHYSICIAN INDICATED THE ARCH WAS "CHALLENGING" AND THE PATIENT HAD A TORTUOUS ANATOMY. IMAGING SHOWED THAT THE ZOOM 71 HAD SEPARATED APPROXIMATELY 10-12 CM FROM THE DISTAL PORTION OF THE CATHETER IN THE INTERNAL CAROTID ARTERY AND DRIFTED INTO THE LEFT M1 SEGMENT. A MICROCATHETER AND STENT RETRIEVER WERE ADVANCED THROUGH THE ZOOM 88 TO THE BROKEN ZOOM 71 SEGMENT. THE STENT RETRIEVER SUCCESSFULLY CAPTURED THE ZOOM 71 SEGMENT AND WAS RETRACTED INTO THE ZOOM 88 ACCESS CATHETER. THE BROKEN SEGMENT, MICROCATHETER, STENT RETRIEVER AND THE ZOOM 88 WERE REMOVED FROM THE PATIENT AS A SYSTEM. THE PATIENT WAS REPORTED STABLE, AND NO PATIENT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293856 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2404502 00812212030450

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Unknown Required Intervention BRITE TIP LONG SHEATH 8F X 45CM| EMBOTRAP| SYNCHRO2 WIRE| ZOOM 88 110CM