BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 4111168 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05568
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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:2134265-2014-06115. IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). AFTER AN UNSPECIFIED BALLOON CATHETER WAS UNABLE TO CROSS THE LESION, A ROTAWIRE FLOPPY AND A ROTA BURR WERE SELECTED FOR USE. ROTABLATION WAS PERFORMED ONCE. RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE BURR. AFTER REMOVING THE BURR, IT WAS NOTICED THAT THE WIRE WAS SEPARATED IN TWO PLACES. AN ATTEMPT TO REMOVE THE FRAGMENTS WITH A NON BSC SNARE WAS UNSUCCESSFUL. A DISSECTION OCCURRED IN THE RCA. THE PATIENT'S BLOOD PRESSURE DECREASED AND SHE COMPLAINED OF CHEST PAIN. 3 NON BSC DRUG ELUTING STENTS WERE DEPLOYED. THE DISSECTION WAS COVERED AND THE PATIENT WAS STABILIZED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS STABLE AT PROCEDURE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592161 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK509

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention