BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAPRO

    MDR report key: 9596414 · Received January 16, 2020

    Report

    Report Number
    2134265-2019-16791
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 23, 2019
    Report Date
    January 16, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729893370
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT: (B)(6). UNIT OF MEASURE: WEIGHT KG. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ROTAWIRE SEPARATION OCCURRED AND WAS NOT RETRIEVED. A 1.75MM ROTAPRO AND A ROTAWIRE WERE SELECTED FOR USE IN A PROCEDURE IN A 90% STENOSED TARGET LESION IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). ABLATION WAS PERFORMED 3 TIMES FOR 44 SECONDS EACH ABLATION. IT WAS NOTED THAT THE ROTATIONAL BURR MOVED FORWARD AND BACKWARD DURING ABLATION WITHOUT STAYING ONE PLACE. THE ANNULUS OF THE ROTABURR DID NOT COME INTO CONTACT WITH THE SPRING TIP OF THE ROTAWIRE. WHEN ATTEMPTING TO REMOVE THE BURR, IT WAS OBSERVED THAT ROTAWIRE SEPARATED ON THE TIP OPAQUE PART DESPITE NO RESISTANCE UPON REMOVAL. THE SEPARATED TIP OF THE ROTAWIRE WAS IN THE PERIPHERY SO THE PHYSICIAN DID NOT REMOVE IT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE USED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61291 ROTAPRO CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 3243 0024279123 08714729893370

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR