BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAWIRE AND WIRECLIP TORQUER

    MDR report key: 11373005 · Received February 24, 2021

    Report

    Report Number
    2134265-2021-02181
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    February 10, 2021
    Report Date
    March 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729144168
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER CITY: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SUBSTANCE ADHERED ON THE DEVICE. A ROTAWIRE AND WIRECLIP TORQUER WAS SELECTED FOR USE. AN UNUSUALITY WAS NOTED AS THERE WAS A SUBSTANCE ADHERING ON THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE SUBSTANCE ADHERING ON THE ROTAWIRE APPEARED TO BE POWDER.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT ON THE DEVICE. DURING PREPARATION A SUBSTANCE WAS OBSERVED TO ADHERE TO THE ROTAWIRE AND WIRECLIP TORQUER. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270614 ROTAWIRE AND WIRECLIP TORQUER CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 3560 0023508854 08714729144168

    Patients

    Seq Age Sex Outcome Treatment
    1