BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 4192760 · Received October 22, 2014

    Report

    Report Number
    2134265-2014-06445
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.:THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 SALINE LEAK OCCURRED. A 1.50MM ROTALINK¿ PLUS WAS SELECTED TO TREAT THE LESION. DURING PREPARATION OUTSIDE OF THE PATIENT, IT WAS NOTED THAT THE SALINE LEAKED FROM THE SHEATH AND THE DEVICE STALLED FROM ITS ROTATION SPEED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671227 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 16632976

    Patients

    Seq Age Sex Outcome Treatment
    1