BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPORT ASPIRTAION CATHETER

    MDR report key: 2963116 · Received February 15, 2013

    Report

    Report Number
    1220452-2013-00012
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MEDTORNIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K050139
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    METHOD: ACTUAL DEVICE USED IN CASE WAS EVALUATED. VISUAL EXAMINATION PERFORMED. THE ACTUAL DEVICE USED DURING THE CASE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE RETURNED REVEALED THAT THE ASPIRATION CATHETER WAS CONNECTED TO A BALLOON CATHETER. THERE IS AN EXTENSION LINE ATTACHED TO THE ASPIRATION CATHETER WITH FLUID IN IT. THE ASPIRATION CATHETER SHAFT IS KINKED AT 2MM, 128CM AND 135CM DISTAL FROM THE STRAIN RELIEF. THE WIRE LUMEN OF THE ASPIRATION CATHETER IS COMPLETELY TORN FROM THE PROXIMAL EXIT PORT TO THE TIP. THE RADIOPAQUE MARKER BAND IS MISSING. THE INITIAL REPORTED EVENT INDICATES THAT THE RADIOPAQUE MARKER BAND IS STILL WITHIN THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES WITHIN THE MANUFACTURING PROCESS. THE EVENT IS CONFIRMED FOR MARKER MISSING. 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 DURING THE PROCEDURE THE RADIOPAQUE MARKER BAND DETACHED FROM THE SHAFT OF THE ASPIRATION CATHETER AND REMAINS INSIDE THE PATIENT'S VESSEL. THE PHYSICIAN INSERTED THE ASPIRATION CATHETER INTO THE PATIENT OVER THE GUIDE WIRE INTO THE VESSEL. THE PHYSICIAN WAS USING AN BALLOON; HOWEVER, COULD NOT ADVANCE TO THE RIGHT CORONARY ARTERY. THE PHYSICIAN THEN NOTICED A MARKER BAND FLOATING IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO CATCH AND REMOVE THE MARKER BAND, HOWEVER UNSUCCESSFUL AND ENDED UP PUSHING IT FORWARD INTO A BRANCH. THE PHYSICIAN PLACED STENTS INTO THE VESSEL. THE PROCEDURE WAS COMPLETED. THE PATIENT IS REPORTED TO BE FINE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67420 EXPORT ASPIRTAION CATHETER CATHETER, EMBOLECTOMY DXE MEDTORNIC, INC 0006230893

    Patients

    Seq Age Sex Outcome Treatment
    1 Other