BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2161437 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02655
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AN INCORRECT READING ON THE GAUGE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED A NON-BSC BALLOON TO THE LESION AND INFLATED THE BALLOON WITH AN ADVANTAGE 26 INFLATION DEVICE, HOWEVER THE INFLATION GAUGE DID NOT MOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANTAGE 26 INFLATION DEVICE AND THE DEPLOYMENT OF A PROMUS STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904527011 0014208536

    Patients

    Seq Age Sex Outcome Treatment
    1 SAPPHIRE BALLOON CATHETER| MACH1 GUIDE CATHETER| RUNTHROUGH GUIDE WIRE