BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTCA CATHETERS

    MDR report key: 789562 · Received November 17, 2006

    Report

    Report Number
    6000093-2006-02384
    Event Type
    Malfunction
    Date Received
    November 17, 2006
    Date of Event
    October 18, 2006
    Report Date
    October 19, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCI TREATMENT PROCEDURE, THE QUANTUM MAVERICK MONORIAL PTCA CATHETER FAILED TO CROSS THE LESION AND THE BALLOON RUPTURED. ACCORDING TO THE CUSTOMER, "THE LESION WAS 99% OF STENOSIS WITH SEVERE CALCIFICATION AND NOT TORTUOUS AT [LEFT ANTERIOR DESCENDING] LAD. THIS UNIT WAS FAILED TO CROSS TO THE LESION. THEREFORE, THE FIRST DILATATION WAS PERFORMED WITH OTHER BALLOON 1.5MM. AFTER THAT, THE BALLOON RUPTURE OCCURRED AT NOMINAL PRESSURE." IT WAS FURTHER REPORTED THAT, "THE QUANTUM MAV MON 15MM X 2.25MM FAILED TO CROSS THE LESION. A 1.5 VOYAGER (GUIDANT) WAS INSERTED AND DILATION WAS PERFORMED. THE 1.5 VOYAGER WAS REMOVED AND THE QUANTUM MAV MON 15MM X 2.25MM WAS REINSERTED AND THIS RUPTURED AT NOMIMAL PRESSURE ON THE INITIAL INFLATION." THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS 'GOOD.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTCA CATHETERS LOX CATHETERS , TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANE LOX BOSTON SCIENTIFIC CORP. QUANTUM MAVERICK 8788322

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN VOYAGER (GUIDANT) _ 1.5MM