BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1052631 · Received May 27, 2008

    Report

    Report Number
    2134265-2008-01503
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY PROCEDURE, BALLOON SEPARATION OCCURRED. THE CALCIFIED LESION BEING TREATED WAS LOCATED IN THE TORTUOUS PROXIMAL TO MID PERONEAL. THE QUANTUM MAVERICK BALLOON WAS ADVANCED THROUGH A CONTRA LATERAL APPROACH WITH DIFFICULTY ENCOUNTERED DUE TO THE CALCIFICATION AND TORTUOSITY. THE BALLOON WAS INFLATED TO UNK ATMS, AND DURING WITHDRAWAL OF THE QUANTUM MAVERICK BALLOON CATHETER THE BALLOON SHEARED OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BALLOON FRAGMENT WITH A SNARE. FOLLOWING REMOVAL, PATENCY OF THE VESSEL WAS CONFIRMED BY ANGIOGRAPHY. NO PT SYMPTOMS OCCURRED DURING THIS EVENT, AND PT STATUS WAS REPORTED AS 'OKAY'. THE PHYSICIAN FELT THAT THE DIFFICULTIES ENCOUNTERED WERE "JUST AN OUTCOME OF A DIFFICULT CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS LOX BOSTON SCIENTIFIC 30X4.0MM 11141633

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention