BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MONORAIL PTCA CATHETER

    MDR report key: 837968 · Received October 18, 2006

    Report

    Report Number
    6000093-2006-02102
    Event Type
    Malfunction
    Date Received
    October 18, 2006
    Date of Event
    September 20, 2006
    Report Date
    September 20, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    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 EVALUATION; 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. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8161222 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCI PROCEDURE INVOLVING A CALCIFIED, HIGHLY TORTUOUS, 100% STENOTIC LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA), THE QUANTUM MAVERICK MONORAIL BALLOON RUPTURED AT 18 ATMS ON THE SECOND INFLATION. THE FIRST INFLATION WAS TO 20 ATMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS 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 15MM X 3.0MM 8161222

    Patients

    Seq Age Sex Outcome Treatment
    1 YR