BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 2032130 · Received March 28, 2011

    Report

    Report Number
    2134265-2011-01003
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE BALLOON CATHETER WAS RETURNED WITH THE GUIDEWIRE IS STUCK INSIDE THE LUMEN. THERE IS 115CM OF THE GUIDEWIRE EXTENDING OUT OF THE TIP AND 55CM OF THE GUIDEWIRE EXTENDING OUT OF THE GUIDEWIRE EXIT NOTCH. THE SHAFT IS BUCKLED/ACCORDIANED 10-15CM DISTALLY FROM THE GUIDEWIRE EXIT NOTCH. THE OUTER DIAMETER OF THE NON-BSC GUIDE WIRE MET SPECIFICATION FOR A COMPATIBLE GUIDE WIRE TO THE DEVICE . DUE TO THE BUCKLED SHAFT, THE GUIDEWIRE WAS UNABLE TO BE REMOVED FROM THE BALLOON CATHETER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE THE BALLOON CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS IN THE POSTEROLATERAL (PL) ARTERY. A MAVERICK 2 MONORAIL 15MM X 1.5MM BALLOON CATHETER WAS ADVANCED OVER A NON-BSC GUIDE WIRE. FOLLOWING INFLATION OF THE BALLOON, THE BALLOON CATHETER BECAME STUCK ON THE WIRE. THE BALLOON AND WIRE ABLE TO BE REMOVED AND EXCHANGED FOR A NEW BALLOON AND WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892815150 13785105

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR BMW WIRE