BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK

    MDR report key: 3970278 · Received July 31, 2014

    Report

    Report Number
    2134265-2014-04484
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A MAVERICK OTW BALLOON CATHETER. VISUAL AND TACTILE INSPECTION WAS PERFORMED; THERE WAS BLOOD IN THE INFLATION LUMEN. THE DEVICE WAS SOAKED IN A WATER BATH TO LOOSEN THE CONTRAST PRIOR TO FUNCTIONAL TESTING. FUNCTIONAL TESTING WAS PERFORMED USING AN INFLATION DEVICE FILLED WITH WATER. THE DEVICE WAS INFLATED AND A STREAM OF WATER EMITTED FROM THE BALLOON. EXAMINATION UNDER MAGNIFICATION REVEALED A BALLOON PINHOLE 1MM FROM THE PROXIMAL MARKERBAND. THERE WERE NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. MAGNIFIED INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE CONFIRMED DAMAGE. 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 BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 15MM 2.50 MAVERICK BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. IT WAS NOTED THAT THE BALLOON RUPTURED. THE NUMBER OF INFLATIONS AND TO WHAT ATMS IS UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 15MM 2.50 MAVERICK BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. IT WAS NOTED THAT THE BALLOON RUPTURED. THE NUMBER OF INFLATIONS AND TO WHAT ATMS IS UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447118 MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7492062015250 15873554

    Patients

    Seq Age Sex Outcome Treatment
    1