BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 2003518 · Received March 1, 2011

    Report

    Report Number
    2134265-2011-00458
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 20MM X 2.5MM MAVERICK2 MONORAIL BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION AND DURING INFLATION A BALLOON RUPTURE OCCURRED AT 10 ATMS. THE NUMBER OF INFLATIONS IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892820250 12722788

    Patients

    Seq Age Sex Outcome Treatment
    1