BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK

    MDR report key: 4170660 · Received October 14, 2014

    Report

    Report Number
    2134265-2014-06156
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    July 20, 2014
    Report Date
    September 19, 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). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (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 MILDLY CALCIFIED UNSPECIFIED TARGET VESSEL. A 15MM 2.50 MAVERICK¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO DILATE THE LESION. THE BALLOON WAS INFLATED TWICE AT AN UNKNOWN PRESSURE. HOWEVER, UPON THE THIRD INFLATION, THE BALLOON RUPTURED AT AN UNSPECIFIED PRESSURE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651490 MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7492062015250 15873554

    Patients

    Seq Age Sex Outcome Treatment
    1