BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET AVX

    MDR report key: 18436734 · Received January 3, 2024

    Report

    Report Number
    2124215-2023-74026
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    September 6, 2023
    Report Date
    January 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729889045
    PMA / PMN Number
    K133629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: THE PRODUCT WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF AN ANGIOJET AVX CATHETER. THE CATHETER SHAFT SHOWED MULTIPLE BENDS AND KINKS. THE DEVICE WAS RECEIVED STUCK INSIDE THE INTRODUCER. THERE WAS SHAFT BUCKLING 9 CM FROM THE PROXIMAL MARKER BAND TO THE TIP. FUNCTIONAL TESTING WAS NOT ATTEMPTED DUE TO THE EXTREME DAMAGE. DURING ANALYSIS AT THE SEVERELY KINKED LOCATION AT 1.5 CM FROM THE PROXIMAL MARKER BAND TO THE DISTAL TIP THE HYPOTUBE WAS CLEARLY BROKEN AND COMPLETELY SEPARATED/MISSING. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED DUE TO THE EXTREME DAMAGE ON THE DEVICE. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE COMPLAINT WAS CONFIRMED FOR ISSUES RELATED TO A BROKEN HYPOTUBE. SHAFT KINKS AND BUCKLING WERE ALSO CONFIRMED. REVIEW OF THE PRODUCT SPECIFICATION INDICATES THE ANGIOJET AVX CATHETER IS COMPATIBLE WITH A 6 FR INTRODUCER SHEATH. THE REPORTED INFORMATION INDICATES THE ANGIOJET AVX CATHETER WAS USED WITH A CORDIS AVANTI 6 FR INTRODUCER; THEREFORE, THERE IS NO INDICATION OF A COMPATIBILITY ISSUE.

    Description of Event or Problem · 0

    REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT HYPOTUBE BREAK OCCURRED. AN ANGIOJET AVX WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. HOWEVER, DURING THE PREPARATION, THE DEVICE FAILED TO PUMP AND PRIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK AND SHAFT BUCKLING 9 CM FROM THE PROXIMAL MARKER BAND TO THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628529 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0030659283 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown