BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATHEROCATH GTO CORONARY ATHERECTOMY CATHETER

    MDR report key: 176526 · Received July 9, 1998

    Report

    Report Number
    2024168-1998-00289
    Event Type
    Injury
    Date Received
    July 9, 1998
    Date of Event
    June 9, 1998
    Report Date
    June 12, 1998
    Manufacturer
    GUIDANT ACS/DVI
    Product Code
    MCX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATHERECTOMY PROCEDURE OF A RESTENOSED MULTI-LINK STENT, THE CUTTER BOUND UP IN THE STENT. THE PHYSICIAN WAS CUTTING AT THE PROXIMAL EDGE OF THE PREVIOUSLY IMPLANTED STENT. ON THE 37TH PASS, THE CUTTER BOUND UP IN THE STENT, THE DRIVE SHAFT TORQUED TO FAILURE, AND THE GUIDEWIRE WAS IMMOBILIZED. THE PHYSICIAN FORCEFULLY REMOVED THE ATHERECTOMY DEVICE OUT OF THE CORONARY, PUTTING THE STENT WITH IT. THE LESION BECAME 100% OCCLUDED. THE PHYSICIAN SUCCESSFULLY PLACED ANOTHER COMPANY'S STENT AT THE EXPLANTATION SITE TO PREVENT SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATHEROCATH GTO CORONARY ATHERECTOMY CATHETER ATHERECTOMY CATHETER MCX GUIDANT ACS/DVI NA 8022051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention MEDKIT 19F SHEATH| TOURGUIDE JCL GUIDE CATHETER| HT S'PORT GUIDE WIRE| LP 90 INFLATION DEVICE| ACS RHV