BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3180008 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04304
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: 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 PROCEDURE OF A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A ROTAWIRE FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 330 CM ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM GUIDE WIRE AND 1.50 MM ROTABLATOR ROTALINK PLUS BURR WAS SELECTED TO TREAT THE TARGET LESION. DURING PROCEDURE, BURR WAS REMOVED AND THE ROTAWIRE WAS IN THE LAD WHEN A NON BSC BALLOON WAS INFLATED. IT WAS THEN NOTICED THAT THE DISTAL PORTION OF THE ROTAWIRE FRACTURED AND WAS DISCONNECTED FROM THE REST OF THE ROTAWIRE. THEY WERE UNABLE TO RETRIEVED THE ROTAWIRE SO THEY PROCEEDED IN STENTING THE FRACTURED ROTAWIRE INTO THE WALL OF THE ARTERY AND LEAVE IT INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280464 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H802228240020

    Patients

    Seq Age Sex Outcome Treatment
    1 87 Required Intervention