BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAWIRE AND WIRECLIP TORQUER

    MDR report key: 12392734 · Received August 31, 2021

    Report

    Report Number
    2134265-2021-11017
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    April 2, 2020
    Report Date
    August 31, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6). INITIAL REPORTER ADDRESS 1: (B)(6). UMIHIKO KANEKO, MD, YOSHIFUMI KASHIMA, MD, TAKURO SUGIE, MD, DAITARO KANNO, MD, AND TSUTOMU FUJITA, MD, ROTABLATOR DRIVESHAFT FRACTURE DUE TO SIGNIFICANT PROXIMAL TORTUOSITY AND ENLARGEMENT CAUSING MASSIVE CORONARY PERFORATION, KOREAN CIRCULATION JOURNAL, VOLUME 50, ISSUE 11, NOV 2020, PAGES 1048-1050, PISSN 1738-5520 EISSN 1738-5555, HTTPS://DOI.ORG/10.4070/KCJ.2020.0136.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT THE DRIVESHAFT FRACTURED AND A PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX) LESION WITH SEVERE PROXIMAL TORTUOSITY AND ENLARGEMENT. A 1.5MM ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM AND A ROTAWIRE CROSSED THE LESION WITH A ROTATIONAL SPEED OF 220,000 RPM. DURING A FINAL POLISHING RUN, THE BURR COLLIDED WITH THE LESION, AND THE DRIVESHAFT PROLAPSED INTO THE DISTAL LEFT MAIN CORONARY ARTERY (LM). THE DRIVESHAFT WAS SUDDENLY FRACTURED, RESULTING IN ELLIS TYPE III PERFORATION OF THE DISTAL LEFT MAIN WITH VASCULAR ECTASIA AND LEFT CIRCUMFLEX ARTERY. AFTER THE IMPLANTATION OF TWO POLYTETRAFLUOROETHYLENE COVERED STENTS, THE LEFT CORONARY ANGIOGRAPHY REVEALED NO CONTRAST EXTRAVASATION. ANGIOGRAPHY OF THE BYPASS GRAFT REVEALED PERSISTENT CONTRAST EXTRAVASATION OF THE LEFT INTERNAL MAMMARY ARTERY TO THE LEFT ANTERIOR DESCENDING ARTERY GRAFT, REQUIRING SURGICAL REPAIR BY FILLING AND SEALING THE PERFORATION SITE WITH SURGICAL COTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296103 ROTAWIRE AND WIRECLIP TORQUER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention