BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK CATHETER

    MDR report key: 1241070 · Received November 20, 2008

    Report

    Report Number
    2134265-2008-04392
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVAL, 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 PROD FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, THE BURR BECAME STUCK IN THE LESION. THE APPROX 30 MM, SEVERELY CALCIFIED LESION WAS LOCATED IN THE PROXIMAL 3.0 MM TO 3.5 MM DIAMETER MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE LESION WAS NOT PRE-DILATED. THE PLATFORM SPEED OF THE ROTALINK 1.75 MM BURR WAS SET AT 108KRPMS. THE ROTALINK 1.75 MM WAS ADVANCED TO THE LESION, HOWEVER, ON AN UNSPECIFIED RUN THE BURR BECAME STUCK IN THE LESION. THE BURR WAS "EVENTUALLY" REMOVED BY UNSPECIFIED MEANS AND NO VESSEL DAMAGE WAS NOTED. THE PHYSICIAN PLACED AN UNSPECIFIED 8FR GUIDE CATHETER AND ADVANCED A 2.25 MM BURR TO THE LESION. IT WAS NOT KNOWN HOW MANY RUNS WERE MADE WITH THE 2.25 MM BURR. IT WAS NOTED THAT THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF THREE OF ANOTHER MFR'S STENTS OF UNK SIZE. THE PT'S STATUS IS REPORTED AS "STABLE".

    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 62 YR Required Intervention X3 ENDEAVOR RESOLUTE STENTS