BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3254629 · Received July 30, 2013

    Report

    Report Number
    2134265-2013-05257
    Event Type
    Injury
    Date Received
    July 30, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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).

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: KONSTANTIN ALEXIOU. ENTRAPPED CORONARY CATHETER REMNANTS AND STENTS. TEX HEART INST J 2006; 33:139-42. UPDATE: DESCRIBE EVENT OR PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THE ROTABLATOR BURR STUCK IN THE VESSEL. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). DURING ABLATION USING A ROTABLATOR BURR, THE BURR STUCK IN THE VESSEL AND REQUIRED SURGICAL REMOVAL.

    Description of Event or Problem · 1

    SAME JOURNAL ARTICLE AS MDR ID 2134265-2013-05243. IT WAS FURTHER REPORTED: THE ROTOBLATOR TIP PERFORATED THE RIGHT CORONARY ARTERY. THE PATIENT WAS SENT TO SURGERY 95 MINUTES AFTER THE DEVICE ENTRAPMENT. THE BURR WAS ABLE TO BE RETRIEVED THROUGH AN AORTOTOMY AND CORONARY ARTERY BYPASS GRAFT (CABG). NO PERIOPERATIVE COMPLICATIONS WERE OBSERVED. THE PATIENT RECEIVED A COMBINATION OF ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355984 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK UNK553

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention