BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 25001709 · Received April 27, 2026

    Report

    Report Number
    2124215-2026-22595
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729228363
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A - PATIENT IDENTIFIER: (B)(6). E1 - INITIAL REPORTER PHONE: (B)(6). GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 1.50MM ROTABLATOR ROTALINK PLUS AND ROTAWIRE-IC WERE SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN PREPARED FOR ROTATIONAL ABLATION AND USED THE GUIDEWIRE FOR CALCIFICATION TREATMENT. AFTER EXCHANGING THE ROTATIONAL ABLATION GUIDEWIRE IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE GUIDEWIRE WAS CONNECTED TO THE BURR. THE GUIDEWIRE CROSSED THE TAIL END OF THE BURR AND WAS SLOWLY INSERTED INTO THE BLOOD VESSEL TO APPROACH THE CALCIFICATION AREA. HOWEVER, DURING THE ROTATIONAL ABLATION PROCESS, IT WAS FOUND THAT THE GUIDEWIRE WAS STUCK TO THE BURR AND COULD NOT BE PUSHED FORWARD OR BACKWARD. AFTER TRYING SEVERAL TIMES, IT WAS NOT POSSIBLE TO PUSH IT. THEREFORE, THE BURR AND GUIDEWIRE WERE REPLACED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279029 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION H749236310030 0037606328 08714729228363

    Patients

    Seq Age Sex Outcome Treatment
    1