BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 20098238 · Received August 29, 2024

    Report

    Report Number
    3014590708-2024-00030
    Event Type
    Death
    Date Received
    August 29, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 29, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    PMA / PMN Number
    K211476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 INFORMATION PROVIDED AND WITH LIMITED CASE IMAGES, THE EXACT CAUSE OF THE VESSEL DISSECTION IS UNKNOWN. THE RELATIONSHIP WITH THE ZOOM 71 DEVICE TO THE VESSEL DISSECTION COULD NOT BE ESTABLISHED. IT IS NOT CLEAR IF THE DISSECTION WAS CAUSED BY THE ZOOM 71, THE GUIDEWIRE, OR OTHER REASONS. 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

    A 36-YEAR-OLD FEMALE PATIENT WAS TREATED FOR AN OCCLUSION AT THE LEFT M2 SEGMENT. ACCESS WAS OBTAINED USING A GUIDEWIRE AND A ZOOM 88. A ZOOM 71 AND ZOOM 35 WERE ADVANCED THROUGH ZOOM 88 TO THE CLOT, AND ASPIRATION WAS APPLIED. THE PHYSICIAN COMPLETED FOUR PASSES USING THE SAME CATHETER COMBINATION WITHOUT REPORTING ANY ISSUES. DURING THE PROCEDURE, IMAGING SHOWED EXTRAVASATION, AND THE PHYSICIAN STATED A VESSEL DISSECTION OCCURRED. ACCORDING TO THE PHYSICIAN IT WAS DIFFICULT TO IDENTIFY THE EXACT ANATOMICAL LOCATION OF THE DISSECTION. THE PHYSICIAN ENDED THE CASE WITHOUT PERFORMING ANY MEDICAL INTERVENTION. THE ZOOM 71 CATHETER AND THE GUIDEWIRE WERE REPORTED TO BE PRESENT AT THE LOCATION OF THE VESSEL DISSECTION. THE PHYSICIAN STATED THAT THE ZOOM 71 DID NOT MALFUNCTION. THE PATIENT PASSED AWAY TWO DAYS LATER POST-PROCEDURE AND ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS ATTRIBUTED TO THE EXTRAVASATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354572 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2404502

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Death| H| L ARISTOTLE 24 WIRE| ZOOM 35| ZOOM 88 SUPPORT