BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 19217390 · Received April 30, 2024

    Report

    Report Number
    3014590708-2024-00016
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 30, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030450
    PMA / PMN Number
    K211476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ZOOM 71 CATHETER WAS RETURNED FOR INVESTIGATION. INVESTIGATION CONFIRMED THE REPORTED SHAFT BREAKAGE. INVESTIGATION DEMONSTRATED STRETCHING AND KINKING ALONG BOTH THE DISTAL AND PROXIMAL SEGMENTS OF THE BROKEN CATHETER SHAFT INDICATING THAT AN AXIAL FORCE WAS APPLIED. STRETCHED CATHETER JACKET MATERIALS WERE OBSERVED ON BOTH THE DISTAL AND PROXIMAL SEGMENTS OF THE ZOOM 71. THE MANUFACTURING RECORDS FOR THE ZOOM 71 WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS. BASED ON THE COMPLAINT INFORMATION PROVIDED AND DEVICE INVESTIGATION THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. A CONTRIBUTING FACTOR TO THE ZOOM 71 DAMAGE IS ATTRIBUTED TO THE PRESENCE OF STENOSIS AT THE CAROTID BULB THAT POTENTIALLY INTERFERED WITH THE RETRACTION OF THE ZOOM 71 RESULTING IN THE CATHETER SHAFT STRETCHING.

    Description of Event or Problem · 0

    THE PATIENT FIRST UNDERWENT A MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION PROCEDURE TO ADDRESS A SUBDURAL HEMATOMA RESULTING FROM A FALL. RADIAL ACCESS WAS ACHIEVED USING A THIRD-PARTY ACCESS CATHETER AND MICROCATHETER FOR COIL DEPLOYMENT. FOLLOWING THE MMA EMBOLIZATION PROCEDURE, A MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED TO REMOVE THE OCCLUSION LOCATED AT THE RIGHT MID-MIDDLE CEREBRAL ARTERY (MCA). THE PATIENT'S ANATOMY WAS TORTUOUS, AND STENOSIS WAS OBSERVED JUST DISTAL TO THE CAROTID BULB, BEFORE THE EXTERNAL CAROTID ARTERY (CA). DURING THE FIRST PASS, ACCESS WAS OBTAINED USING AN RDL, A 0.038" GLIDEWIRE, AND A THIRD-PARTY SELECT CATHETER. THE RDL WAS PARKED AT THE MID-EXTERNAL CA. A ZOOM 71 WAS ADVANCED TO THE FACE OF THE CLOT, AND AFTER REMOVING THE THIRD-PARTY SELECT CATHETER, ASPIRATION WAS APPLIED. WHILE RETRACTING THE ZOOM 71 THROUGH THE RDL RESISTANCE WAS FELT (LOCATION OF THE RESISTANCE WAS NOT SPECIFIED). THE TREATING PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE ZOOM 71 HAD STRETCHED PROXIMAL TO THE TIP. THE ENTIRE ZOOM 71 AND RDL WERE SUCCESSFULLY REMOVED TOGETHER AS A SYSTEM. THE PATIENT ACHIEVED COMPLETE REPERFUSION WITH A TICI 3 SCORE. POST PROCEDURE, THE PATIENT WAS STABLE WITH NO REPORTED SEQUELAE. AT THE BACK TABLE, WHEN THE TECHNICIAN ATTEMPTED TO SEPARATE AND PULL THE ZOOM 71 THROUGH THE RDL, THE ZOOM 71 SHAFT FRACTURED (EXACT LOCATION OF THE BREAK WAS NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146825 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2329902 00812212030450

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female 0.038" GLIDEWIRE| ECHELON MICROCATHETER| EXPEDION MICROWIRE| RDL| SIM2 SELECT0401| ZOOM 35