BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET AVX

    MDR report key: 12297395 · Received August 9, 2021

    Report

    Report Number
    2134265-2021-10126
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 17, 2021
    Report Date
    August 9, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729889045
    PMA / PMN Number
    K133629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE PRODUCT RETURN CONTAINED AN ANGIOJET AVX. THE ASSEMBLY, SUPPLY LINE, SHAFT, TIP, AND SPIKE LINE WERE ALL VISUALLY EXAMINED FOR POTENTIAL DAMAGE. INSPECTION OF THE SHAFT REVEALED SEVERE DAMAGE AND STRETCHING STARTING 1CM FROM THE TIP, AND GOING DOWN UNTIL 3.5 CM FROM THE TIP. A FUNCTIONAL TEST WAS PERFORMED. THE PUMP WAS PLACED INTO THE ULTRA DRIVE CONSOLE AND THE DEVICE PRIMED WITH NO COMPLICATION. THE DEVICE WAS RUN FOR A TOTAL TIME OF 90 SECONDS IN THROMBECTOMY MODE. THE DEVICE STAYED WITHIN THE EXPECTED RANGE OF THE PRODUCT. NO ADDITIONAL CATHETER OR SHAFT DAMAGE WAS NOTED DURING TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARM. AN ANGIOJET AVX WAS USED IN A THROMBECTOMY PROCEDURE. DURING WITHDRAWAL, IT WAS NOTED THAT THE CATHETER LOOKED LIKE IT WAS ABOUT TO SEPARATE BETWEEN THE TWO MARKERS AND THE HOLES WERE STRETCHED OUT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193279 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0025627421 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1