BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK 2 (TM)

    MDR report key: 2221403 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03527
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    SAME CASE AS MDR # 2134265-2011-03526. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING. THE PHYSICIAN ADVANCED A 15MM X 1.5MM MAVERICK 2 BALLOON CATHETER TO THE TARGET LESION. THE BALLOON REACHED 7ATMS AND RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PHYSICIAN ADVANCED A DIFFERENT 15MM X 1.5MM MAVERICK 2 BALLOON CATHETER TO THE TARGET LESION. THE BALLOON REACHED 12ATMS AND RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER AND TWO UNSPECIFIED STENTS WERE DEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK 2 (TM) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX H7493892815150

    Patients

    Seq Age Sex Outcome Treatment
    1