BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING MONORAIL

    MDR report key: 1190830 · Received September 24, 2008

    Report

    Report Number
    2134265-2008-02792
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053118
    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 CAROTID ARTERY STENTING (CAS) PROCEDURE, BALLOON INFLATION DIFFICULTY AND A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. THE STENOSIS AND CALCIFICATION OF THE LESION ARE UNKNOWN. THE TORTUOSITY OF THE VESSEL IS UNKNOWN. THE STERLING 3.5 X 30/135 MM BALLOON WAS ADVANCED TO THE LESION. HOWEVER, THE BALLOON WAS NOT INFLATED PROPERLY AND THE BALLOON RUPTURED AT 6ATM. THE INFLATION TIME IS UNKNOWN. THE BALLOON WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING MONORAIL DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11641358

    Patients

    Seq Age Sex Outcome Treatment
    1 CORDIS BRITE TIP GUIDE CATHETER| CAPTURE GUIDEWIRE| JOHNSON AND JOHNSON ANGIOGUARD EMBOLI