BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIROFLEX VG THROMBECTOMY SET

    MDR report key: 3866200 · Received May 23, 2014

    Report

    Report Number
    2183460-2014-00008
    Event Type
    Other
    Date Received
    May 23, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BAYER INTERVENTIONAL
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANGIOJET SPIROFLEX CATHETER THAT WAS IN USE DURING THE EVENT HAS NOT BEEN PROVIDED TO BAYER AND HAS BEEN RETAINED BY THE SITE; THEREFORE, NO FURTHER INVESTIGATION COULD BE PERFORMED. BASED ON THE LIMITED INFO, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE ALLEGED ISSUE. IN THE EVENT THAT ADD'L INFO IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS INFO DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. THIS EVENT IS CONSIDERED A REPORTABLE EVENT AS INTERVENTION WAS REQUIRED TO RETRIEVE THE BROKEN DISTAL PORTION OF THE ANGIOJET SOLEN OMNI DEVICE.

    Description of Event or Problem · 1

    AFTER COMPLETION OF A LEFT ILIAC PTA/STENT PROCEDURE, ANGIOGRAPHY WAS PERFORMED WHICH REVEALED A DOWNSTREAM THROMBUS IN THE LEFT POPLITEAL ARTERY. THE ANGIOJET CATHETER WAS REINSERTED AND, AS IT WAS BEING ADVANCED TO THE THROMBUS, THE SHEATH BACKED UP ON THE STENT STRUTS OF THE RECENTLY PLACED LET ILIAC STENT WHICH PROHIBITED FORWARD OR BACKWARD ADVANCEMENT OF THE CATHETER. THIS CAUSED THE CATHETER TO SEPARATE INTO TWO PIECES, THE DISTAL PORTION OF WHICH REMAINED INSIDE THE PT. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN PORTION FROM THE PT. A SECOND ANGIOJET CATHETER AND SUBSEQUENT PTA/STENT WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309056 SPIROFLEX VG THROMBECTOMY SET THROMBECTOMY CATHETER DXE BAYER INTERVENTIONAL 106608-001 157665

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention