BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²?

    MDR report key: 3954981 · Received July 24, 2014

    Report

    Report Number
    2134265-2014-04262
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 30, 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

    DEVICE EVALUATED BY MFR.; RETURNED PRODUCT CONSISTED OF A MAVERICK2 BALLOON CATHETER. THE BALLOON WAS TIGHTLY FOLDED. THE HYPOTUBE WAS COMPLETELY SEPARATED 23CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. 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 A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 2.00MM X 12MM MAVERICK2 BALLOON CATHETER WAS SELECTED FOR USE. THE DEVICE WAS ADVANCED TO THE LESION; THE MAVERICK2 SHAFT BROKE DUE TO THE CALCIFICATION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434820 MAVERICK²? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892812200 16718743

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR