BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 19778657 · Received July 18, 2024

    Report

    Report Number
    3014590708-2024-00024
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 18, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ZOOM 71 CATHETER WAS RETURNED FOR INVESTIGATION. INVESTIGATION CONFIRMED MARKER BAND DETACHMENT. INVESTIGATION OF THE RETURNED DEVICE SHOWED SIGNIFICANT DAMAGE TO THE MATERIALS OF THE DISTAL SECTION OF THE CATHETER NEAR THE TIP INCLUDING STRETCHING AND TEARING. THE DAMAGE INDICATES AN AXIAL FORCE WAS APPLIED TO THE CATHETER WHICH RESULTED IN THE MATERIAL SEPARATION AND DETACHMENT OF THE RADIOPAQUE MARKER BAND FROM THE CATHETER. THE RADIOPAQUE MARKER BAND WAS NOT RETURNED FOR INVESTIGATION. THE ZOOM 88 CATHETER WAS ALSO NOT RETURNED FOR INVESTIGATION. BASED ON THE PROVIDED COMPLAINT INFORMATION, REVIEW OF THE CASE IMAGES, AND WITHOUT THE RETURN OF ADJUNCTIVE ACCESS CATHETER, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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 83-YEAR-OLD MALE 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 MID CERVICAL. DURING THE FIRST PASS, A ZOOM 71 ASPIRATION CATHETER WAS ADVANCED THROUGH ZOOM 88 TO THE CLOT IN THE LEFT MCA. ASPIRATION WAS THEN APPLIED TO THE ZOOM 71. THE ZOOM 71 WAS RETRACTED INTO ZOOM 88 AND RESISTANCE WAS NOTED WHEN THE TIP OF ZOOM 71 REACHED THE TIP OF ZOOM 88. THE TREATING PHYSICIAN CONTINUED REMOVAL OF THE ZOOM 71 THROUGH THE ZOOM 88. AFTER THE ZOOM 71 REMOVAL, IT WAS NOTED THAT THE RADIOPAQUE MARKER BAND WAS MISSING. IMAGING WAS CONDUCTED AND SHOWED THE ZOOM 71 MARKER BAND REMAINING IN THE PATIENT. THE PHYSICIAN DETERMINED THAT THE MARKER BAND WAS NON-FLOW LIMITING AND DECIDED TO NOT ATTEMPT REMOVAL. THE ZOOM 88 WAS REMOVED FROM THE PATIENT. NO DEVICE DEFICIENCY WAS OBSERVED ON THE ZOOM 88. A NEW CATHETER SYSTEM CONSISTING OF A THIRD-PARTY GUIDE CATHETER, A THIRD-PARTY ASPIRATION CATHETER, AND A ZOOM 35 WAS USED TO COMPLETE THE PROCEDURE. THE CLOT WAS REMOVED WITH THE ZOOM 35 CATHETER. THE PATIENT ACHIEVED COMPLETE REPERFUSION WITH A TICI 3 SCORE AND IS REPORTED TO BE STABLE. THERE WERE NO OTHER PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917526 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2334201 00812212030450

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other ARISTOTLE 0.018" WIRE.| PENUMBRA BMX 96 90CM.| PENUMBRA SELECT 6F SIM.| RED 72.| STRYKER SYNCRO SELECT 0.014" WIRE.| ZOOM 35.| ZOOM 88.