BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK CATHETER

    MDR report key: 1151307 · Received September 4, 2008

    Report

    Report Number
    2134265-2008-02520
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT #: 2134265-2008-02521. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, A WIRE DETACHMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). ABLATION WAS SUCCESSFULLY PERFORMED, FIRST WITH A 1.5MM BURR AND THEN WITH A 1.25MM BURR. DURING REMOVAL OF THE 1.25MM BURR IN DYNAGLIDE, SOMETHING "WENT AWRY" AND THE ROTAWIRE TIP WAS NOTED REMAINING IN THE PT. ATTEMPTS WERE MADE FOR 1 1/2 HOURS TO RETRIEVE THE GUIDE WIRE TIP, INCLUDING INSERTION OF AN UNSPECIFIED FILTERWIRE, HOWEVER THE ATTEMPTS WERE UNSUCCESSFUL. A FOLLOW UP THORACIC SURGICAL CONSULT DETERMINED THAT NO SURGICAL INTERVENTION WAS NECESSARY. PT STATUS WAS REPORTED AS STABLE AND PT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK CATHETER MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CVA21

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other