BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1082639 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02071
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE BALLOON CATHETER WIL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT BALLOON CATHETER 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. AS NO DEVICE WAS RECEIVED FOR ANALYSIS IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE HAS BEEN ATTRIBUTED TO OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD THAT THE PT ANATOMY OR OTHER PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED DIFFICULTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOTIC, DE NOVO AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS SHUNT VEIN. VASCULAR ACCESS WAS GAINED THROUGH UNSPECIFIED FEMORAL ARTERY. THE STERLING OVER-THE-WIRE 4.0MM X 40MM BALLOON CATHETER WAS ADVANCED TO THE LESION FOR PRE-DILATATION AND RUPTURED AT 13 ATMS, THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PT INJURIES OR COMPLICATIONS. THE PATIENT'S STATUS WAS REPORTED AS "NO PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING OVER-THE-WIRE DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11375548

    Patients

    Seq Age Sex Outcome Treatment
    1 EVEREST| MEDIKIT 4F