BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2101806 · Received May 25, 2011

    Report

    Report Number
    2134265-2011-02064
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). 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

    SAME CASE AS 2134265-2011-02065. IT WAS REPORTED THAT DURING A PERIPHERAL ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A COMPLETE OCCLUSION OF THE VESSEL OCCURRED. THE 1.75 ROTABLATOR BURR HAD DIFFICULTY BEING ADVANCED OVER THE WIRE TO TREAT A LESION IN THE LOWER EXTREMITY. A KINK WAS DISCOVERED ON THE 330CM FLOPPY ROTAWIRE GUIDE WIRE, HOWEVER, EVENTUALLY THE 1.75MM ROTABLATOR BURR REACHED THE LESION. ONE ABLATION PASS WAS COMPLETED AND THE BURR WAS PULLED BACK SLIGHTLY. AS THEY WERE TRYING TO ADVANCE THE BURR BACK OVER THE WIRE TO COMPLETE ANOTHER ABLATION PASS, THEY ENCOUNTERED RESISTANCE WITH THE ROTAWIRE GUIDE WIRE. ONCE THE BURR GOT TO THE LESION, AN ATTEMPT WAS MADE TO ABLATE AGAIN, BUT THEY HEARD AN UNUSUAL NOISE. THEY PULLED THE WHOLE ROTABLATOR SYSTEM AND ROTAWIRE OUT OF THE BODY. UPON REMOVAL, IT WAS NOTICED THAT THE ROTAWIRE DISTAL TO THE BURR WAS COILED UP. AN ANGIOGRAM WAS TAKEN WHICH SHOWED A 1.75MM LUMEN PRESENT POST ROTABLATOR. THE PHYSICIAN THEN DECIDED TO PERFORM A DIRECTIONAL ATHERECTOMY TREATMENT PROCEDURE WITH A NON-BSC DEVICE. AFTER COMPLETING THIS PORTION OF THE PROCEDURE, IT WAS FOUND THAT THE VESSEL HAD COMPLETELY SHUT DOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680040

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FOX HOLLOW DIRECTIONAL ATHERECTOMY DEVICE| FLOPPY ROTAWIRE 330CM