BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1181529 · Received September 25, 2008

    Report

    Report Number
    2134265-2008-02772
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Report Date
    August 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A SHAFT FRACTURE OCCURRED. THE LESION WAS LOCATED IN THE DIAGONAL INTERVENTRICULAR ARTERY (IVA). THE TORTUOSITY AND DEGREE OF CALCIFICATION ARE UNKNOWN. THE MAVERICK 20MM X 2.5MM BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED AN UNSPECIFIED NUMBER OF TIMES TO UNKNOWN ATMS. UPON WITHDRAWAL, RESISTANCE WAS ENCOUNTERED AND THE SHAFT OF THE BALLOON CATHETER FRACTURED. THE ENTIRE DEVICE WAS RETRIEVED BY UNSPECIFIED MEANS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER INTERVENTION. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD". NO ADDITIONAL INFORMATION REGARDING THE EVENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC MAVERICK2 20 / 2.5 11880577

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR