BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1083391 · Received July 28, 2008

    Report

    Report Number
    2134265-2008-02081
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS DID NOT CONFIRM THE PACKAGE SEAL COMPRISED STATED IN THE COMPLAINT. THE RETURNED PACKAGE WAS RECEIVED OPEN. THE RETURNED PACKAGE WHICH INCLUDED TO DEVICE WAS INSPECTED AND A VENDOR SEAL WAS FOUND TO BE ACTIVATED, INDICATING IT WAS HEAT SEAL PROPERLY DURING MANUFACTURING. THERE WERE NO VOIDS FOUND IN THE SEAL. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED, BECAUSE THERE IS NO EVIDENCE OF ANY MATERIAL, MANUFACTURING, OR PERFORMANCE SPECIFICATION NON-CONFORMANCES RELATED TO THE COMPLAINT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A COMPROMISED STERILE PACKAGE BARRIER WAS NOTED UPON UNPACKING A QUANTUM MAVERICK MONORAIL 20MM X 2.5MM BALLOON CATHETER. THE DEVICE HAD NO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    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 20X2.25 MM 9433889

    Patients

    Seq Age Sex Outcome Treatment
    1