BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET AVX RHEOLYTIC THROMBECTOMY CATHETER

    MDR report key: 670842 · Received February 3, 2006

    Report

    Report Number
    2183460-2006-00001
    Event Type
    Other
    Date Received
    February 3, 2006
    Date of Event
    December 6, 2005
    Report Date
    January 31, 2006
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN JAN. 2006, REP RECEIVED A CALL FROM TECHNICAL SUPPORT, REQUESTING THAT REP CALL A DOCTOR ABOUT AN INCIDENT WITH ANGIOJET. REP CALLED HIM IMMEDIATELY. DR. WAS STILL IN THE CASE INVOLVING A FEMALE PATIENT THAT WAS BEING TREATED WITH 45CM AJ CATHETER FOR A THROMBOSED SYNTHETIC HEMODIALYSIS ACCESS GRAFT. A DISTAL PIECE OF THE AJ HAD FRACTURED AND REMAINS IN THE PATIENT. THE FRACTURED PIECE INCLUDES THE DISTAL MARKER BAND. HE ENDED UP STENTING OVER THE PIECE SO THAT IF WOULD NOT EMBOLIZE. THAT IS, AT THE END OF THE PROCEDURE, THE FRACTURED PIECE REMAINS IN THE PATIENT, PINNED AGAINST THE GRAFT WALL BY A STENT. DR. COMMENTED THAT THIS PATIENT'S VASCULAR ACCESS WILL BE LOST, BUT NOT DUE ENTIRELY TO THE AJ FRACTURE. HE SAID THAT HE HAD USED AJ MANY TIMES AND THIS HAS NOT HAPPENED BEFORE. HE WAS USING AJ IN A STRAIGHT SEGMENT, SAID THAT HE COULD NOT ATTRIBUTE THE FRACTURE TO ANYTHING SPECIFIC, THINKS CATHETER WAS JUST DEFECTIVE. REP TOLD HIM THAT REP WAS UNAWARE OF ANY REPORTS OF AJ FRACTURES DURING AV DECLOTS, REP ASKED IF HE HAD TRIED TO SNARE IT. HE DID ATTEMPT TO SNARE, BUT WAS UNSUCCESSFUL. REP ASKED IF PATIENT IS STABLE--YES. REP ASKED HIM TO SEND THE AJ CATHETER BACK TO POSSIS SO THAT CO CAN EVALUATE. HE WILL DO THIS. HE COULD NOT TALK FURTHER, AS PATIENT WAS STILL ON THE TABLE. REP TOLD HIM THAT POSSIS WILL CONTACT HIM AGAIN EARLY NEXT WEEK TO DISCUSS FURTHER. AS REPORTED BY THE PMI CLINICAL SPECIALIST; RT STATES THAT DOCTORS AJ AV GRAFT UPON PULLING CATHETER BACK IN SHEATH, THE TIP BROKE OFF. THE FLUURO MACHINE WASNT'T LEFT ON DURING ENTIRE CASE SO THE TECHNICIAN STATES THAT THE WIRE COULD HAVE COME BACK INTO CATHETER THEN READVANCED OUT WINDOWS. DOCTORS STATE THAT THEY MET RESISTANCE PULLING CATHETER BACK INTO SHEATH. DR. USE AJ OTEN AND THIS IS THE FIRST TIME THIS HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET AVX RHEOLYTIC THROMBECTOMY CATHETER AVX 50 DXE POSSIS MEDICAL, INC. AVX 57440

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention