BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING MONORAIL

    MDR report key: 1011676 · Received March 10, 2008

    Report

    Report Number
    2134265-2008-00715
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, 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 PRODUCT 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 PRIOR TO AN UNSPECIFIED PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. ANOTHER MANUFACTURER'S 0.014 GUIDE WIRE AND THE STERLING 3.0 MM X 40MM X 135CM BALLOON CATHETER WERE PROPERLY PREPPED WITHOUT DIFFICULTY. THE BALLOON CATHETER WAS ADVANCED OVER THE GUIDE WIRE, HOWEVER, UPON REACHING THE MID-POINT OF THE GUIDE WIRE THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE PHYSICIAN APPLIED FORCE TO THE BALLOON CATHETER AND WAS ABLE TO REMOVE THE DEVICE FROM THE GUIDE WIRE. FOLLOWING REMOVAL, IT WAS NOTED THAT THE GUIDE WIRE DID NOT SUSTAIN DAMAGE. NEITHER THE GUIDE WIRE NOR THE BALLOON CATHETER ENTERED THE PATIENT. A DIFFERENT 0.035 GUIDE WIRE AND ANOTHER OF THE SAME BALLOON CATHETER WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PT'S STATUS IS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING MONORAIL DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 9401888

    Patients

    Seq Age Sex Outcome Treatment
    1 190CM GRAND SLAM 0.014 GUIDE WIRE