BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPORT XT ASPIRATION CATHETER

    MDR report key: 2934292 · Received January 30, 2013

    Report

    Report Number
    1220452-2013-00006
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDTORNIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K061958
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - MATERIAL SEPARATION EVALUATION IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE USED DURING THE CASE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE RETURNED ASPIRATION CATHETER REVEALED THAT THE EXTENSION LINE WAS ENGAGED. A KINK WAS NOTED ON THE ASPIRATION CATHETER 18CM FROM THE STRAIN RELIEF. THE WIRE LUMEN IS TORN FROM THE PROXIMAL EXIT PORT TO THE DISTAL TIP PORT OF ENTRY AND THE MARKER BAND IS MISSING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES WITHIN THE MANUFACTURING PROCESS. A CINE FILM OF THE PROCEDURE WAS RETURNED AND REVIEWED. THE CINE CONFIRMS THAT THE MARKER BAND IS STILL INSIDE THE PATIENT. HOWEVER THERE IS NO OTHER EVIDENCE OF WHEN THE MARKER BAND DETACHED FROM THE ASPIRATION CATHETER. THE EVENT IS CONFIRMED FOR MARKER BAND DETACHMENT. THE ANALYSIS IS COMPLETE AS OF TODAY (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT THE RADIOPAQUE MARKER BAND BECAME DETACHED FROM THE SHAFT DURING THE PROCEDURE AND REMAINS INSIDE THE PATIENT. THE PROCEDURE WAS A STEM IN THE MIDDLE RIGHT CORONARY ARTERY. THE PHYSICIAN INSERTED AND USED THE ASPIRATION CATHETER. THE PHYSICIAN FELT A LITTLE RESISTANCE ADVANCING WITH THE CATHETER BUT THE PHYSICIAN WAS ABLE TO EVENTUALLY PERFORM ASPIRATION. DURING THE WITHDRAWAL OF THE ASPIRATION CATHETER, THE RADIOPAQUE MARKER BAND DETACHED AND REMAINED ENTRAPPED INTO THE DESCENDING AORTA. THE PHYSICIAN INSERTED A STENT INTO THE PATIENT. THE MARKER HAS MOVED INTO THE ABDOMINAL AORTA AND NOW IS FIXED THERE. NO CLINICAL SEQUELS. THE PATIENT IS STABLE IN GOOD CONDITION BUT STILL UNDER OBSERVATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41315 EXPORT XT ASPIRATION CATHETER CATHETER, EMBOLECTOMY DXE MEDTORNIC, INC 0006537526

    Patients

    Seq Age Sex Outcome Treatment
    1