BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1023832 · Received April 2, 2008

    Report

    Report Number
    2134265-2008-00950
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT #: 2134265-2008-00949. IT WAS REPORTED THAT DURING AN ILIOFEMORAL STENTING PROCEDURE, DIFFICULTIES WERE ENCOUNTERED REMOVING THE GUIDE WIRE FROM THE STENT DELIVERY SYSTEM CATHETER, AND THERE WAS FORMATION OF A CLOT. THE VESSEL WAS MODERATELY TORTUOUS. FOLLOWING ADVANCEMENT OF THE DIAGNOSTIC CATHETER, THE PHYSICIAN ADVANCED THE AMPLATZ WIRE OVER THE BIFURCATION. WHEN HE REMOVED THE DIAGNOSTIC CATHETER TO ADVANCE THE STENT DELIVERY SYSTEM, HE NOTED A STICKY RESIDUE ON THE WIRE. HE THEN REMOVED THE AMPLATZ WIRE AND WIPED IT DOWN AND CONTINUED WITH THE PROCEDURE. THE PHYSICIAN INITIALLY ATTRIBUTED THE STICKINESS TO THE AMPLATZ GUIDE WIRE, HOWEVER, WHEN IT WAS NOTED THAT THE DIAGNOSTIC CATHETER WAS USED PAST EXPIRATION THE PHYSICIAN WAS THEN UNCLEAR. NEXT, AS THEY WERE ADVANCING THE UNISTEP STENT DELIVERY SYSTEM CATHETER ON THE WIRE, THE PHYSICIAN NOTED RESISTANCE. WHEN HE REMOVED THE STENT DELIVERY SYSTEM CATHETER, THE AMPLATZ WIRE CAME OUT AS WELL. THE PHYSICIAN STATED "IT FELT LIKE THE AMPLATZ WAS STUCK INSIDE THE STENT CATHETER". FOLLOWING REMOVAL OF THE WIRE FROM THE CATHETER OUTSIDE OF THE BODY, THE PHYSICIAN WAS ASKED TO DEPLOY THE STENT A LITTLE BIT OUTSIDE OF THE PATIENT. THE STENT EASILY DEPLOYED AND WAS CAPTURED AGAIN. HOWEVER, THE PHYSICIAN THOUGHT THERE WAS A CLOT INSIDE OF THE STENT CATHETER, AND THEREFORE USED ALL NEW DEVICES TO CONTINUE THE PROCEDURE SUCCESSFULLY. CLEXANE GIVEN DURING PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS REPORTED AS 'STABLE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM FGE CATHETER, BILLIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 0009765563

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR SIM 2 DIAGNOSTIC CATHETER (EXPIRED 2006)