BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET AVX

    MDR report key: 11966650 · Received June 9, 2021

    Report

    Report Number
    2134265-2021-07156
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 15, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729889045
    PMA / PMN Number
    K133629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF AN ANGIOJET AVX CATHETER. THE PUMP ASSEMBLY, EFFLUENT/SUPPLY LINE, SHAFT, TIP, AND SPIKE LINE WERE VISUALLY EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. THE CATHETER SHAFT SHOWED A KINK LOCATED 36.5CM FROM THE TIP. FUNCTIONAL TESTING WAS COMPETED PER DEVICE PREPARATION. THE PUMP WAS INSERTED INTO THE ULTRA DRIVE UNIT CONSOLE. THE PUMP AND DEVICE PRIMED AS DESIGNED. THE DEVICE WAS RUN FOR A PERIOD OF 120 SECONDS IN THE THROMBECTOMY MODE. THE DEVICES PRESSURE WAS WITHIN THE NORMAL RANGE. NO FAILURES OR ERROR CODES WERE NOTICED DURING THE TESTING. NO LEAKS WERE NOTICED DURING TESTING. THE ANGIOJET DEVICE IS ISO-VOLUMETRIC WHICH MEANS IT INFUSES FLUID AND ASPIRATES FLUID AT THE SAME RATE. ASPIRATION TESTING WAS PERFORMED BY FILLING A 100CC BEAKER WITH WATER. THE DEVICES TIP WAS SUBMERGED IN THE FLUID AND RUN FOR A PERIOD OF 1 MINUTE. THE WATER LEVEL AT THE END OF TESTING WAS 98CC WHICH SHOWS THE DEVICE WAS ASPIRATING AS DESIGNED. 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 A LOSS OF ASPIRATION OCCURRED. TWO ANGIOJET AVX CATHETERS WERE SELECTED FOR TREATMENT. HOWEVER, AFTER CONNECTING THE DEVICE TO THE ANGIOJET THROMBECTOMY MACHINE, EACH ANGIOJET AVX CATHETER MALFUNCTIONED AND DID NOT PROPERLY ASPIRATE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF ASPIRATION OCCURRED. TWO ANGIOJET AVX CATHETERS WERE SELECTED FOR TREATMENT. HOWEVER, AFTER CONNECTING THE DEVICE TO THE ANGIOJET THROMBECTOMY MACHINE, EACH ANGIOJET AVX CATHETER MALFUNCTIONED AND DID NOT PROPERLY ASPIRATE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862115 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0027235758 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1