BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER

    MDR report key: 310092 · Received December 19, 2000

    Report

    Report Number
    2024168-2000-00318
    Event Type
    Injury
    Date Received
    December 19, 2000
    Date of Event
    November 24, 2000
    Report Date
    November 24, 2000
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MCX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DCA PROCEDURE TREATING AN IN-STENT RESTENOSIS IN A 3.0 VESSEL, THE PROXIMAL LAD, RESISTANCE WAS ENCOUNTERED WHILE TRYING TO ADVANCE THE ATHERECTOMY CATHETER TO THE LESION, AND THE DEVICE WOULD NOT PASS THROUGH THE STENT. RESISTANCE WAS ENCOUNTERED WHILE TRYING TO WITHDRAW THE DEVICE FROM THE PT, AND UPON REMOVAL FROM THE ANATOMY, THE NOSECONE (POLYURETHANE) WAS FOUND TO BE SEPARATED FROM THE DEVICE. A BALLOON CATHETER WAS USED TO PUSH THE NOSECONE INTO THE DISTAL LAD, AND THE SEPARATED PIECE REMAINS IN THE VESSEL. THE PT HAD A NON-Q-WAVE MI DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER CORONARY ATHERECTOMY CATHETER MCX GUIDANT VASCULAR INTERVENTION NA 0092651

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention| S HT S'PORT,| DVI RHV,| GRAND SLAM,| 2.5/15 TERUMO HAYATE BALLOON,| TOURGUIDE 10FJCL4 GUIDING CATHETER,| IVUS CATHETER.| NEO'S SOFT GUIDE WIRES,| 3.0/10 CUTTING BALLOON CATHETER,