BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MONORAIL PTCA CATHETER

    MDR report key: 2923281 · Received April 6, 2006

    Report

    Report Number
    6000093-2006-02721
    Event Type
    Malfunction
    Date Received
    April 6, 2006
    Date of Event
    March 16, 2006
    Report Date
    March 17, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFO BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE QUANTUM MAVERICK MONORAIL PTCA CATHETER BALLOON RUPTURED AT 18 ATMS ON THE INFLATION. THE NUMBER OF INFLATIONS AND TO WHAT ATMS IS UNK. THE LESION BEING TREATED WAS A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 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 QUANTUM MAVERICK MONORAIL PTCA CATHETER PTCA CATHETER LOX BOSTON SCIENTIFIC CORP. 12 MM X 3.5 MM 8357685

    Patients

    Seq Age Sex Outcome Treatment
    1