BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET AVX

    MDR report key: 18614530 · Received January 31, 2024

    Report

    Report Number
    2124215-2024-05100
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729889045
    PMA / PMN Number
    K133629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF AN ANGIOJET AVX CATHETER. MEDIA WAS RETURNED IN THE FORM OF A PHOTO. THE PHOTO WAS REVIEWED WHICH SHOWED THE TIP DAMAGE WHICH WAS CONFIRMED DURING ANALYSIS. THE PUMP ASSEMBLY, EFFLUENT/SUPPLY LINE, SHAFT, TIP, AND SPIKE LINE WERE VISUALLY EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. THE CATHETER SHAFT SHOWED SHAFT KINKS AT 42 CM AND 37.5 FROM PROXIMAL MARKER BAND. NO GUIDEWIRE WAS RECEIVED WITH THE DEVICE AND NO GUIDEWIRE WAS INSERTED DUE TO THE EXTREME DAMAGE TO THE DEVICE. FUNCTIONAL TESTING WAS NOT ATTEMPTED DUE TO THE EXTREME DAMAGE TO THE DEVICE. DURING ANALYSIS, DAMAGE WAS OBSERVED MEASURING FROM THE PROXIMAL MARKER BAND AT 1.5 CM TO 4.5 CM, THE ENTIRE SECTION OF THE SHAFT WAS STRETCHED WITH THE HYPOTUBE DETACHED AND SEPARATED AT 1.5 CM FROM THE PROXIMAL MARKER BAND. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER STUCK, AND TIP FRAYED OCCURRED. AN ANGIOJET AVX CATHETER WAS ADVANCED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE RADIOPAQUE MARKERS WERE SUDDENLY FARTHER APART THAN NORMAL. THE DEVICE WAS PULLED OUT TO INVESTIGATE, BUT THE CATHETER WAS STUCK AND WOULD NOT COME BACK OUT OF THE SHEATH. IT WAS STUCK TO THE .035 NON-BOSTON SCIENTIFIC GLIDEWIRE AND COULD NOT GET EITHER OF THE DEVICE BACK OUT. THE THREE DEVICES HAD TO BE REMOVED ALL TOGETHER OUT OF THE PATIENT AT THE SAME TIME. ONCE THE PHYSICIAN HAD PULLED THE WIRE, THE CATHETER AND THE SHEATH OUT TOGETHER, A PORTION OF THE WIRE WAS STILL IN THE PATIENT. THEY WERE ABLE TO FREE THE CATHETER AND SHEATH FROM THE WIRE AND INSERTED A NEW SHEATH TO MAINTAIN ACCESS AND WAS ABLE TO REMOVE THE WIRE. MOREOVER, IT WAS NOTED THAT THE CATHETER TIP WAS FRAYED AND MANGLED. THE PROCEDURE WAS COMPLETED THIS DEVICE AS THEY ARE FAR ALONG IN THE CASE AND HAD GOTTEN ENOUGH CLOT OUT AND DID NOT NEED ANOTHER CATHETER OR PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260904 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0032066769 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female