BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1162198 · Received September 16, 2008

    Report

    Report Number
    2134265-2008-02665
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 26, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE LESION BEING TREATED WAS 90% STENOSED LESION WITHOUT CALCIFICATION IN A MODERATELY TORTUROUS SHUNT. THERE WAS NO DIFFICULTY INFLATING THE STERLING OTW BALLOON. FIVE INFLATIONS WERE PERFORMED WITH A MAXIMUM INFLATION OF 14 ATMS. THE PROCEDURE WAS COMPLETED WITH THIS BALLOON, BUT THE PHYSICIAN CLAIMED THAT THE CONTRAST MEDIA GOT OUT FROM THE BALLOON VERY SLOW WHILE DEFLATING FOR EACH DEFLATION. IT SEEMED THAT THE CONTRAST MEDIA WAS STAGNATED AT THE DISTAL OF THE BALLOON. THE PHYSICIAN DIDN'T NOTICE ANOMALIES AFTER BALLOON REMOVAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT 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 11645058

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RADIFOCUS| INFLATION DEVICE: MEDTRONIC EVEREST| INTRODUCER SHEATH: TERUMO4FR