BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 2901557 · Received January 8, 2013

    Report

    Report Number
    2134265-2012-08263
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    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

    AGE AT TIME OF EVENT: (B)(6). 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 STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY. A 2.0X20MM NON-BSC BALLOON CATHETER WAS ADVANCED AND INFLATED. NEXT A 2.5X24MM TAXUS ELEMENT STENT WAS ADVANCED FOR TREATMENT, BUT WAS NOT ABLE TO CROSS THE LESION. THEN A 2.5X20MM QUANTUM MAVERICK BALLOON WAS ADVANCED, BUT IT WAS NOT ABLE TO CROSS THE LESION. A 2.5X15MM APEX BALLOON WAS THEN ADVANCED AND INFLATED, HOWEVER THE BALLOON RUPTURED AT 5 ATMS. THEN A 2.5MM NON-BSC BALLOON CATHETER WAS ADVANCED BUT WAS NOT ABLE TO CROSS THE LESION. FINALLY A 2.5MM NON-BSC BALLOON CATHETER WAS ADVANCED AND INFLATED BUT IT ALSO RUPTURED. THE PROCEDURE WAS COMPLETED WITHOUT STENTING. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8823 APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895915250 15354669

    Patients

    Seq Age Sex Outcome Treatment
    1