BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET AVX

    MDR report key: 8712237 · Received June 19, 2019

    Report

    Report Number
    2134265-2019-07094
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 19, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE PUMP ASSEMBLY, EFFLUENT/SUPPLY LINE, SHAFT, TIP, PISTON, AND SPIKE LINE WERE VISUALLY INSPECTED. BLOOD WAS PRESENT INSIDE THE DEVICE AND ALMOST 100 ML OF BLOOD IN THE ATTACHED WASTE BAG, WHEN RECEIVED. THE INTRODUCER SHEATH WAS RECEIVED ON THE DISTAL SHAFT OF THE CATHETER AND WAS ABLE TO BE REMOVED WITH NO ISSUES. THERE WAS NO GUIDEWIRE STUCK IN THE ANGIOJET DEVICE OR RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE DEVICE REVEALED THAT THERE WERE NUMEROUS KINKS THROUGHOUT THE SHAFT OF THE DEVICE. THE DISTAL SHAFT OF THE CATHETER WAS STRETCHED AND BUCKLED FROM THE PROXIMAL TO DISTAL MARKERBANDS. MICROSCOPIC EXAMINATION REVEALED THAT THE HYPOTUBE WAS SEPARATED FROM THE JET BODY. FUNCTIONAL TESTING WITH A TEST GUIDEWIRE WAS NOT POSSIBLE DUE TO THE DAMAGE OF THE DISTAL SHAFT. INSPECTION OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER BECAME STUCK ON THE GUIDEWIRE. AN ANGIOJET AVX CATHETER WAS SELECTED FOR A FISTULAGRAM IN THE BRACHIAL ARTERY. AFTER A LONG PASS, THE CATHETER BECAME STUCK ON THE UNSPECIFIED GUIDEWIRE. THE CATHETER AND THE GUIDEWIRE WERE PULLED OUT TOGETHER. THE ARTERY WAS RE-WIRED AND ANOTHER OF THE SAME CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504426 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0023819556 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1