BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELESCOPE GUIDE EXTENSION CATHETER

    MDR report key: 9321436 · Received November 14, 2019

    Report

    Report Number
    9612164-2019-04749
    Event Type
    Injury
    Date Received
    November 14, 2019
    Date of Event
    November 8, 2019
    Report Date
    January 17, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K183353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE ANALYSIS SUMMARY: THERE APPEARS TO BE TWO GUIDEWIRES IN USE. THE GUIDE CATHETER IS PRESENT IN THE LEFT MAIN ARTERY. A BALLOON PUMP DEVICE IS EVIDENT IN THE IMAGE. WITH THE FLOW OF CONTRAST, AN OCCLUSION IS EVIDENT, DISTAL TO THE GUIDE CATHETER. IT APPEARS THE GUIDE WIRES HAVE PASSED THROUGH THE OCCLUSION. THE GUIDEWIRES APPEAR TO HAVE BEEN REPOSITIONED, DISTALLY IN THE LEFT MAIN ARTERY. A BALLOON APPEARS TO HAVE BEEN ADVANCED THROUGH THE GUIDE CATHETER AND APPEARS TO BE POSITIONED AT A BI-FURCATION OF THE LEFT MAIN ARTERY. BALLOON INFLATION BEGINS TO DILATE THE LESION. THE TELESCOPE GEC APPEARS TO HAVE BEEN ADVANCED THROUGH THE GUIDE CATHETER. IT ALSO APPEARS THAT A BALLOON WAS ADVANCED TO POST-DILATE THE MOST DISTAL STENT IN THE LESION. THE GUIDE EXTENSION CATHETER (GEC) IS NO LONGER VISIBLE, IT APPEARS THAT THE TELESCOPE GEC HAS BEEN RETREATED PROXIMALLY, A BALLOON WAS THEN ADVANCED TO THE LESION, JUST PROXIMAL TO THE FIRST DEPLOYED STENT MOST LIKELY TO POST -DILATE THE SECOND STENT. THE TELESCOPE GEC AND GUIDE CATHETER HAVE BEEN ADVANCED DISTALLY INTO THE LEFT MAIN ARTERY, THE SECOND STENT IS BEING POST- DILATED. USING A MEASURE TOOL, THE APPROXIMATE DISTANCE BETWEEN THE DISTAL TELESCOPE MARKER-BAND AND THE PROXIMAL BALLOON MARKER-BAND IS 2.08 MM. THE DISTAL TELESCOPE MARKER-BAND IS 2 MM PROXIMAL TO THE DISTAL TIP OF THE TELESCOPE GEC. IT APPEARS MOST LIKELY THAT THE BALLOON OF THE STENT DELIVERY SYSTEM MAY NOT HAVE FULLY EXITED THE TELESCOPE GEC PRIOR TO THE BALLOON EXPANSION. IT APPEARS THE POSITION OF THE DEVICES WITHIN THE LEFT MAIN ARTERY CHANGED DURING THE POST-DILATION OF THE SECOND STENT, WITH THE PROXIMAL SECTION OF THE BALLOON POSITIONED WITHIN THE DISTAL SECTION OF THE TELESCOPE GEC. IT APPEARS MOST LIKELY THAT THE TELESCOPE TIP DETACHMENT HAS OCCURRED AT THIS POINT AND HAD MIGRATED DISTALLY INTO THE LEFT MAIN ARTERY. THE DISTAL MARKER-BAND OF THE TELESCOPE GEC IS POSITIONED IMMEDIATELY DISTAL TO THE PROXIMAL MARKER-BAND OF THE BALLOON, MOST LIKELY FOR RETRIEVAL. RETRIEVAL EFFORTS FAILED, AND THE DISTAL TELESCOPE MARKER-BAND MIGRATED DISTALLY INTO THE VESSEL. A DEVICE IS USED TO ATTEMPT TO RETRIEVE THE TELESCOPE DISTAL MARKER-BAND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DISTAL LEFT MAIN ARTERY EXHIBITED 95% STENOSIS. THE LESION WAS PREDILATED USING A 2.5 X 20 MM BALLOON. AN ATTEMPT WAS MADE TO ADVANCE A 3.5 X 22MM RESOLUTE ONYX STENT, HOWEVER IT WAS UNABLE TO CROSS THE LESION. THE TELESCOPE DEVICE WAS THEN USED TO ATTEMPT DELIVERY OF THE 3.5 X 22MM RESOLUTE ONYX STENT, BUT WAS UNSUCCESSFUL. TWO NON-MEDTRONIC STENTS WERE OVERLAPPED IN THE LEFT MAIN. THE BALLOON AND THE TELESCOPE DEVICE WERE WITHDRAWN IN ATTEMPT TO REMOVE BOTH DEVICES FROM THE BODY. THIS RESULTED IN LOSS OF WIRE POSITION. A SNARE WAS ATTEMPTED MULTIPLE TIMES TO REMOVE THE EMBOLIZED TIP, BUT WERE UNSUCCESSFUL. A 2.0 BALLOON WAS THEN USED IN ATTEMPT TO REMOVE THE EMBOLIZED TIP, WHICH WAS ALSO UNSUCCESSFUL. A NON-MEDTRONIC GUIDE EXTENSION CATHETER AND 2.0 X 8 MM BALLOON WERE USED TO SANDWICH THE EMBOLIZED PORTION. THE EMBOLIZED PORTION WAS REMOVED ALONG WITH THE NON-MEDTRONIC GUIDE EXTENSION CATHETER AND 2.0 X 8 MM BALLOON AS ONE UNIT. DEVICE EVALUATION: THE DEVICE RETURNED WITH A DETACHMENT OF THE DISTAL TIP OF THE DEVICE. THE DISTAL MARKER BAND WAS NOT PRESENT ON THE DEVICE AND WAS NOT RETURNED FOR ANALYSIS. THE MATERIAL IMMEDIATELY DISTAL TO THE DISTAL BOND APPEARED STRETCHED. NO DEFORMATION WAS EVIDENT TO THE REMAINDER OF THE DEVICE. THE INNER LUMEN OF THE DEVICE COULD NOT BE VERIFIED, AS RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO PASS A 0.0540¿ PATENCY BALL, DISTALLY THROUGH THE STRETCHED SECTION OF THE DEVICE. NO OTHER DEFORMATION WAS EVIDENT TO THE REMAINDER OF THE DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A 6 FRENCH TELESCOPE GUIDE EXTENSION CATHETER TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION LOCATED IN THE DISTAL LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS REMOVED FROM THE PACKAGING AND PREPPED AS PER THE IFU. TWO STENTS WERE OVERLAPPED IN THE LEFT MAIN. THE DISTAL PORTION OF THE LM WAS POST DILATED WITHOUT COMPLICATION. IT WAS REPORTED THAT THE TELESCOPE WAS THEN PULLED BACK TO POST DILATE THE PROXIMAL LM HOWEVER THE TIP OF THE TELESCOPE WAS OBSERVED TO HAVE DETACHED. THE TIP EMBOLISED TO THE MID-LAD WHEN THE TELESCOPE, GUIDE AND WIRE WERE REMOVED. THE TIP WAS EVENTUALLY REMOVED FROM THE BODY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120045 TELESCOPE GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 0009815459

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention