BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET AVX

    MDR report key: 8085342 · Received November 19, 2018

    Report

    Report Number
    2134265-2018-62959
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    November 6, 2018
    Report Date
    December 10, 2018
    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

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WAS STUCK ON THE WIRE. AN ANGIOJET AVX CATHETER AND A 180AMPLATZ GUIDEWIRE WERE SELECTED FOR AN AV GRAFT DECLOT PROCEDURE. DURING THE PROCEDURE, THE CATHETER WOULD NOT PULL BACK OVER THE WIRE. ONE RING GOT CAUGHT ON THE WIRE AND WOULD NOT LET THE PHYSICIAN RETRACT THE WIRE. THE TUBING TO THE CONSOLE WAS CUT IN ORDER TO REMOVE THE WIRE AND CATHETER TOGETHER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. RETURNED PRODUCT CONSISTED OF PORTION OF THE AVX THROMBECTOMY SYSTEM WITH APPROXIMATELY 12CM OF THE .035" GUIDEWIRE FOR THE RELATED COMPLAINT. MAJORITY OF THE EFFLUENT LINE AND SUPPLY LINE WERE CUT-OFF AND NOT RETURNED FOR ANALYSIS. THE PUMP AND PUMP ASSEMBLY WERE ALSO NOT RETURNED FOR ANALYSIS. THE EFFLUENT/SUPPLY LINE AND SHAFT WERE VISUALLY INSPECTED. BLOOD WAS PRESENT OUTSIDE AND INSIDE THE DEVICE WHEN RECEIVED. VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE EFFLUENT AND SUPPLY LINES WERE CUT-OFF 7CM DISTAL OF THE BARB LUER AND THE SHAFT WAS KINKED 22CM AND 25CM DISTAL OF THE STRAIN RELIEF. THE DISTAL PORTION OF THE SHAFT WAS DETACHED AND STRETCHED AT THE PROXIMAL MARKERBAND AND PROXIMAL WINDOW. THE MARKERBAND WAS MOVED DISTALLY ON THE OUTER SHAFT. THE HYPOTUBE WAS ALSO DETACHED 1CM DISTAL OF THE PROXIMAL WINDOW. THE REST OF THE DISTAL SHAFT, INCLUDING THE TIP, AND THE HYPOTUBE WERE NOT RETURNED FOR ANALYSIS. THE DISTAL SADDLE AND JET BODY WERE DETACHED AND RECEIVED ON THE RETURNED GUIDEWIRE. THE SADDLE WAS DAMAGED AND PORTION OF THE JET BODY WAS DETACHED FROM THE HYPOTUBE AND STILL CONNECTED TO THE DISTAL SADDLE. THE SADDLE/JET BODY WAS ABLE TO BE REMOVED FROM THE GUIDEWIRE WITH SOME RESISTANCE, AS THE GUIDEWIRE WAS DAMAGED WITH COATING PEELING OFF. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS STUCK ON THE WIRE. AN ANGIOJET AVX CATHETER AND A 180AMPLATZ GUIDEWIRE WERE SELECTED FOR AN AV GRAFT DECLOT PROCEDURE. DURING THE PROCEDURE, THE CATHETER WOULD NOT PULL BACK OVER THE WIRE. ONE RING GOT CAUGHT ON THE WIRE AND WOULD NOT LET THE PHYSICIAN RETRACT THE WIRE. THE TUBING TO THE CONSOLE WAS CUT IN ORDER TO REMOVE THE WIRE AND CATHETER TOGETHER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927485 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0022627677 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR