BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²?

    MDR report key: 3242960 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-05077
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A MAVERICK 2 BALLOON CATHETER WITH THE SHELF BOX AND CARRIER TUBE (HOOP). THE BATCH NUMBER ON THE RETURNED DEVICE AND PACKAGING MATCHED THE REPORTED BATCH NUMBER. THERE WAS BLOOD IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED. THERE WAS A PINHOLE AND SCRATCH IN THE BALLOON WALL MATERIAL LOCATED OVER THE DISTAL MARKERBAND. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. 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

    REPORTABLE BASED ON ANALYSIS ON (B)(4) 2013. IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY PROCEDURE, CROSSING DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). AFTER CROSSING AN UNSPECIFIED GUIDEWIRE, A 3.75 MM X 30 MM MAVERICK BALLOON CATHETER WAS SELECTED TO CROSS THE TARGET LESION HOWEVER; THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344152 MAVERICK²? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892830370 15282899

    Patients

    Seq Age Sex Outcome Treatment
    1