BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETCH2

    MDR report key: 5473416 · Received March 2, 2016

    Report

    Report Number
    5473416
    Event Type
    Injury
    Date Received
    March 2, 2016
    Date of Event
    January 20, 2016
    Report Date
    January 22, 2016
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN TWO SEPARATE CASES, THE FETCH 2 RX ASPIRATION CATHETER WAS FOUND TO HAVE FRACTURED AFTER RESISTANCE WAS FELT WHILE ADVANCING THE CATHETER THROUGH THE SHEATHS. IN THE FIRST CASE THE FETCH DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY SHEATH. AFTER THE FIRST ASPIRATION, RESISTANCE WAS FELT AT THE SHEATH INSERTION SITE. THE DISTAL END OF THE FETCH DEVICE WAS NOTED TO BE BROKEN WITH A SLENDER WIRE REMAINING BETWEEN THE TWO BROKEN ENDS. DOCTORS WERE ABLE TO REMOVE BOTH THE DEVICE AND THE SHEATH AND EXCHANGE THE SHEATH WITHOUT HARM TO THE PATIENT. IN THE SECOND CASE, THE PATIENT PRESENTED WITH A STEMI AND REQUIRED AN EMERGENT CARDIAC CATHETERIZATION. DURING THE PROCEDURE, ANGIOGRAPHY DEMONSTRATED A LARGE CLOT BURDEN. THE INTERVENTIONAL CARDIOLOGIST WISHED TO REMOVE THE CLOT USING THE FETCH 2 ASPIRATION CATHETER. RESISTANCE WAS FELT WHILE ATTEMPTING TO ADVANCE THE CATHETER THROUGH THE GUIDE - THE CATHETER WAS SEEN TO BE FRACTURED ON X-RAY. BOTH THE DISTAL AND PROXIMAL PIECES REMAINED CONNECTED BY A THIN WIRE AND WERE ABLE TO BE REMOVED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130540 FETCH2 CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 192915

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR