BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ZOOM REPERFUSION CATHETER

    MDR report key: 10909469 · Received November 26, 2020

    Report

    Report Number
    3014590708-2020-00006
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    October 24, 2020
    Report Date
    November 25, 2020
    Manufacturer
    IMPERATIVE CARE INC
    Product Code
    NRY
    UDI-DI
    00812212030191
    PMA / PMN Number
    K202182
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION RESULTS OF THE RETURNED DEVICE CONFIRMED THAT THE DISTAL SECTION OF THE CATHETER WAS SEPARATED. THE RETURNED DEVICE DETACHED AT 0.4 CM FROM THE DISTAL TIP, AND THE REMAINING SHAFT MEASURED AT 137.8CM. THE DETACHED PORTION INCLUDES A SLIGHTLY FOLDED MARKER BAND, STRETCHED JACKET MATERIAL, AND COIL. A KINK WAS PRESENT AT 15.0CM FROM THE TIP OF THE REMAINING SHAFT. IT IS UNCERTAIN IF THIS KINK WAS PRESENT DURING THE PROCEDURE OR WAS A RESULT OF HANDLING DAMAGE AFTER REMOVAL FROM THE PATIENT. BASED ON PROVIDED CASE INFORMATION, RESISTANCE WAS ENCOUNTERED, AND THE ZOOM 71 CONTINUED TO BE RETRACTED AGAINST RESISTANCE. IF THE DEVICE IS CONSTRAINED AND FORCEFULLY RETRACTED AGAINST RESISTANCE, THE DEVICE MAY STRETCH AND DETACH. THE ROOT CAUSE OF THE RESISTANCE AND DETACHMENT IS UNABLE TO BE DETERMINED AS THE PROVIDED CASE IMAGES DID NOT CAPTURE THE PERTINENT VESSEL ANATOMY AT MOMENT OF DETACHMENT. PER INSTRUCTIONS FOR USE, THE DEVICES SHOULD NOT BE WITHDRAWN AGAINST RESISTANCE WITHOUT CAREFUL ASSESSMENT OF THE CAUSE UNDER FLUOROSCOPY. IF THE CAUSE CANNOT BE DETERMINED, WITHDRAW ALL DEVICES AS A SINGLE UNIT. THE MANUFACTURING RECORDS OF THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY. APPROPRIATE TESTING AND INSPECTION WAS COMPLETED TO ENSURE THE DEVICE MET MINIMUM TENSILE SPECIFICATION AND IS KINK RESISTANT. THE DISTAL SECTION UNDERGOES 100% VISUAL INSPECTION AND IS FREE OF VISUAL DEFECTS OR PROTRUSIONS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3014590708-2020-00007.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE ON (B)(3) TO TREAT OCCLUSION WITHIN THE MID BASILAR ARTERY. PATIENT DISPLAYED UNDERLYING ATHEROSCLEROSIS AT THE OCCLUSION SITE. ACCESS WAS OBTAINED AT THE DISTAL VERTEBRAL ARTERY USING THE ZOOM 88T 110CM WHICH WAS ADVANCED OVER A COMPETITOR ANGIOGRAPHIC CATHETER AND A 035 GUIDEWIRE. ZOOM 71 REPERFUSION CATHETER WAS SUBSEQUENTLY ADVANCED UNSUPPORTED TO THE SITE OF THE OCCLUSION AND SOME CLOT WAS REMOVED THROUGH THE ZOOM 71 CATHETER. A TOTAL OF TWO PASSES WERE PERFORMED. ZOOM 71 WAS PULLED INTO ZOOM 88 (TIP STILL INTACT) WITH RESISTANCE SEEN ON WITHDRAWAL. THE TIP SEPARATED INSIDE ZOOM 88 BUT WAS NOT NOTICED BY THE PHYSICIAN. COMPETITOR DEVICES WERE USED TO RETRIEVE MORE CLOT AND PHYSICIAN SAW THE TIP IN THE VERTEBRAL ARTERY. TIP WAS REMOVED USING STENT RETRIEVER AND COMPETITOR INTERMEDIATE CATHETER. THE PHYSICIAN PROCEEDED TO PERFORM ANGIOPLASTY TO ADDRESS THE MID BASILAR ATHEROSCLEROSIS WITH NO FURTHER ISSUES. THE CASE WAS COMPLETED WITH NO ADDITIONAL CLINICAL EVENT. PATIENT WAS NOTED TO BE STABLE POST OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377720 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE INC ICRC071137 V2014901 00812212030191

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention