BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 8709004 · Received June 18, 2019

    Report

    Report Number
    2134265-2019-07038
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    May 1, 2019
    Report Date
    June 18, 2019
    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

    DATE OF EVENT: USED THE FIRST DATE OF THE MONTH OF THE AWARE DATE AS NO EVENT DATE WAS PROVIDED.

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT PERFORATION OF THE ARTERY OCCURRED. A ROTAWIRE AND A ROTABLATOR BURR WERE SELECTED FOR USE. DURING A ROTABLATION PROCEDURE OF THE LEFT MAIN CORONARY ARTERY (LMCA) AND LEFT CIRCUMFLEX ARTERY (LCX), PERFORATION OF THE OSTIAL LEFT CIRCUMFLEX ARTERY (LCX) OCCURRED. MULTIPLE ATTEMPTS OF BALLOON TAMPONADE WERE DONE ALONG WITH A NON BSC COVERED STENT DEPLOYED FROM THE PROXIMAL LCX INTO THE LMCA. SUBSEQUENTLY, AN ACUTE EXCLUSION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY FROM THE CORONARY CIRCULATION WAS OBSERVED. A DUAL LUMEN CATHETER AND STIFF WIRE WAS ADVANCED THROUGH THE SIDE PORT TOWARDS THE OCCLUDED LAD TO FENESTRATE THE MEMBRANE OF THE COVERED STENT. IN ADDITION, A SERIES OF BALLOONS USED TO DILATE THE FENESTRATION IN THE COVERED STENT TO RESTORE A NORMAL FLOW. NO FURTHER PATIENT COMPLICATIONS REPORTED. TREATMENT OF ROTABLATION-INDUCED OSTIAL LEFT CIRCUMFLEX PERFORATION BY PAPYRUS COVERED STENT AND ITS FENESTRATION TO RECOVER THE LEFT ANTERIOR DESCENDING ARTERY DURING CHIP PROCEDURE. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2019: 93 (6) P.E331-E336.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502915 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ROTAWIRE AND WIRECLIP TORQUER