BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1083386 · Received July 28, 2008

    Report

    Report Number
    2134265-2008-02109
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 2, 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 WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT BALLOON CATHETER COULD NOT BE COMPLETED. 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 PATIENT ANATOMY OR OTHER PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED DIFFICULTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED AND SEVERELY CALCIFIED LESION WAS LOCATED TORTUOUS LEFT COMMON ILIAC ARTERY (CIA). VASCULAR ACCESS WAS GAINED THROUGH THE LEFT FEMORAL ARTERY BY A RETROGRADE APPROACH. THE STERLING OVER THE WIRE 7.0MM X 40MM X 80CM BALLOON CATHETER WAS ADVANCED TO THE LESION FOR PRE-DILATATION AND INFLATED SLOWLY TO 10ATMS. THE BALLOON RUPTURED AT 10ATMS, ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT 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 11651613

    Patients

    Seq Age Sex Outcome Treatment
    1 6F TERUMO SHEATH| CRUISE GUIDE WIRE