BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2010058 · Received March 8, 2011

    Report

    Report Number
    2134265-2011-00508
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATION BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ENCOUNTERED DIFFICULTY WHILE ADVANCING THE FLOPPY ROTAWIRE GUIDE WIRE TO THE TARGET LESION, MAKING SEVERAL ATTEMPTS. THE PHYSICIAN THEN ADVANCED A NON-BSC WIRE SUCCESSFULLY ACROSS THE LESION, AND USED A MAVERICK OVER-THE-WIRE BALLOON CATHETER TO EXCHANGE THE WIRE TO THE FLOPPY ROTAWIRE GUIDE WIRE WHEN A DISSECTION OCCURRED IN THE DISTAL LAD. THE PHYSICIAN THEN ADVANCED A 2.75 X 15MM APEX BALLOON TO THE DISSECTION TO TREAT IT. THE PHYSICIAN CONTINUED WITH ANGIOPLASTY AND STENTING PROXIMAL TO THE DISSECTION, BEING UNABLE TO ADVANCE A STENT TO THE DISSECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA H802228240020 13459340

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BMW GUIDE WIRE| MAVERICK OTW