BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 2833938 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-06877
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: 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 DURING A PERCUTANEOUS CORONARY ANGIOPLASTY PROCEDURE A BALLOON DEFLATION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DIAGONAL OF THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 2.25 X 12 MM APEX MONORAIL BALLOON CATHETER WAS INFLATED INSIDE AN UNSPECIFIED RESTENOSED STENT IN THE MID LAD. THE BALLOON WAS INFLATED AT 6 ATMS FOR 45 SECONDS AND UPON DEFLATION THE BALLOON WOULD NOT COMPLETELY DEFLATE. THE CATHETER AND HEMO VALVE WERE INSPECTED AND THE PHYSICIAN WAITED ABOUT 2 MINUTES; THEN THE BALLOON WAS INFLATED AT 8 ATMS AND UPON DEFLATION WAS ABLE TO DEFLATE COMPLETELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895912220 0015511132

    Patients

    Seq Age Sex Outcome Treatment
    1