BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK? BURR

    MDR report key: 4231710 · Received November 6, 2014

    Report

    Report Number
    2134265-2014-06731
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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

    IT WAS REPORTED THAT A VESSEL PERFORATION OCCURRED. A 1.25MM ROTALINK¿ BURR WAS USED AND ADVANCED TO TREAT THE EXTREMELY HIGH CALCIFICATION AND EXTREMELY HIGH TORTUOUS TARGET LESION LOCATED AT THE RIGHT CORONARY ARTERY(RCA). DURING PROCEDURE, UPON ABLATION OF THE RCA, A VESSEL PERFORATION OCCURRED. AN UNSPECIFIED BALLOON CATHETER WAS USED TO SEAL THE VESSEL PERFORATION. DUE TO THE VESSEL CALCIFICATION, NO OTHER DEVICES WERE ABLE TO BE INTRODUCED. THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT AS HE HAD A LEFT ANTERIOR DESCENDING LESION AS WELL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713671 ROTALINK? BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680020

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention