BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 5650850 · Received May 12, 2016

    Report

    Report Number
    2134265-2016-03780
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    February 17, 2016
    Report Date
    April 15, 2016
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 VIA FACILITY MEDWATCH 5060676 THAT THE PATIENT CODED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 1.25MM ROTALINK¿ PLUS WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE DYNAGLIDE MODE POWERED UP WHEN THE CONSOLE WAS TURNED ON. THE PHYSICIAN WAS ABLE TO TURN OFF THE DYNAGLIDE MODE AND THE ROTATION SPEED WAS SET AT 165,000RPM AS THE BURR WAS LOADED ON THE WIRE. HOWEVER, IT WAS NOTED THAT THE BURR WAS UNABLE TO EXIT FROM THE GUIDE CATHETER AND WAS UNABLE TO ADVANCE TO THE DISTAL END/TIP OF THE ROTAWIRE. SUBSEQUENTLY, THE DYNAGLIDE MODE WAS RE-ENABLED; HOWEVER, THE CONSOLE WAS UNABLE TO SWITCH OUT FROM DYNAGLIDE MODE. THE PATIENT'S STATUS WAS NOTED TO HAVE DECLINED AND THE PATIENT CODED, THUS, THE PHYSICIAN OPTED TO ABORT THE PROCEDURE. THE PATIENT WAS THEN SENT FOR EMERGENCY CORONARY BYPASS SURGERY. THE PATIENT¿S CONDITION AFTER SURGERY IS UNKNOWN; HOWEVER, THEY WERE DISCHARGED FROM THE OPERATING ROOM TO THE INTENSIVE CARE UNIT. NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306370 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention