BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2061223 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02700
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IN THIS CASE, IT WAS REPORTED THE RX TREK WAS ATTEMPTING TO ADVANCE THROUGH A PREVIOUSLY DEPLOYED STENT WHERE SOME OF THE STENT STRUTS WERE NOT FULLY APPOSED TO THE VESSEL WALL, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT AN INTERACTION WITH THE STENT STRUTS RESULTED IN AN INTERACTION WITH THE BALLOON, RESULTING IN THE BALLOON ENTRAPPED WITHIN THE STENT STRUTS. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER WAS NOT REPORTED. THE PROFILE DIMENSIONS ON ALL BALLOON CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SAPHENEOUS VEIN GRAFT (SVG) FROM THE OBTUSE MARGINAL (OM1) AND THE DISTAL CIRCUMFLEX (CX). A STENT HAD BEEN IMPLANTED IN THE OSTIUM OF THE OM1 IN A PRIOR PROCEDURE AND SOME OF THE STRUTS WERE STICKING OUT INTO THE SVG. THE PROCEDURE WAS TO TREAT DISEASE IN THE DISTAL CX USING THE KISSING BALLOON TECHNIQUE. A NON-ABBOTT GUIDE WIRE (GW) WAS PLACED DOWN THE SVG TO THE DISTAL CX AND A BMW HI-TORQUE GW WAS PLACED IN THE OM1. THE 2.5 X 15 MM TREK BALLOON CATHETER WAS THEN ADVANCED, BUT IT CAUGHT ON THE STRUTS OF THE IMPLANTED STENT. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER, BUT IT COULD NOT BE REMOVED. THE HUB OF THE CATHETER WAS CUT OFF AND A GUIDE LINER WAS ADVANCED IN AN EFFORT TO FREE UP THE BALLOON AND HELP REMOVE THE CATHETER, BUT IT WAS UNSUCCESSFUL. SEVERAL OTHER ATTEMPTS WERE MADE TO DETACH THE BALLOON FROM THE STENT STRUTS AND REMOVE THE CATHETER, BUT WERE UNSUCCESSFUL AND AFTER APPROXIMATELY 5 HOURS THE PROCEDURE WAS ABORTED. THE PATIENT REMAINS HOSPITALIZED AND IS STABILIZED ON LIFE SUPPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R GUIDE WIRE: ATW 300, HI-TORQUE BMW 190