BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAPRO

    MDR report key: 23302094 · Received October 15, 2025

    Report

    Report Number
    2124215-2025-71379
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    August 28, 2025
    Report Date
    October 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729975144
    PMA / PMN Number
    P900056/S166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER ADDRESS 1: (B)(6) HOSPITAL. G4 - PREMARKET / 510(K) #: P900056/S166. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR PRODUCT ANALYSIS. A VISUAL INSPECTION OF THE ROTAPRO CONSOLE REVEALED A BROKEN ADVANCER CONNECTOR PORT. NO OTHER PROBLEM WAS DETECTED DURING RETURNED PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPEED COULD NOT BE ADJUSTED AND THE PROCEDURE WAS CANCELLED. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO CHANGE THE RPM ON THE UNIT KNOB. THE SET SPEED WAS AT 150 RPM AND THE OBSERVED MAXIMUM ROTATION SPEED WAS AT 150 RPM. THE SPEED KNOB WAS NOT RESPONSIVE AND ADJUSTABLE, AND THE RPMS DID NOT GO HIGHER THAN 167 RPM. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004580 ROTAPRO CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 3259 RP000526 08714729975144

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown