BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JETI PERIPHERAL THROMBECTOMY CATHETERS

    MDR report key: 19052419 · Received April 5, 2024

    Report

    Report Number
    2024168-2024-04342
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 5, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    QEZ
    UDI-DI
    08717648351402
    PMA / PMN Number
    K213565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. IT IS UNKNOWN IF JETI CATHETER INTERACTED WITH THE PREVIOUSLY IMPLANTED STENT; THEREFORE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN OCCLUDED AORTIC GRAFT IN THE ILIAC ARTERY. THE 8FR JETI HYDRODYNAMIC THROMBECTOMY CATHETER PASSED THROUGH THE OCCLUDED SEGMENT TWO TIMES. ANGIOGRAPHY SHOWED THE LEFT LIMB WAS PATENT. BALLOON ANGIOPLASTY WAS PERFORMED IN TWO AREAS OF RESIDUAL STENOSIS. AN ANGLED CATHETER PASSED THROUGH THE AORTA TO PERFORM THE FINAL ANGIOGRAPHY RUNS WHEN IT WAS NOTED THE IMPLANTED STENT HAD MIGRATED FROM THE LEFT COMMON ILIAC AND WAS FREE FLOATING IN THE AORTA. PER THE PHYSICIAN, IT IS UNKNOWN IF THE JETI CATHETER OR THE ANGLED CATHETER CAUSED THE STENT TO DISLODGE AND MIGRATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758057 JETI PERIPHERAL THROMBECTOMY CATHETERS ASPIRATION THROMBECTOMY CATHETER QEZ ABBOTT VASCULAR 3092861 08717648351402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown