BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX? PUSH

    MDR report key: 3131769 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03672
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE AND VESSEL PERFORATION OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE "HEAVILY" CALCIFIED AND "HEAVILY" TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM X 12MM APEX PUSH BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. THE BALLOON WAS INFLATED TO 20 ATMOSPHERES ON THE FIRST INFLATION HOWEVER IT RUPTURED AT 20 ATMOSPHERES ON THE SECOND INFLATION AND A PERFORATION OF THE ARTERY OCCURRED. THE BALLOON WAS REMOVED INTACT OUT OF THE PATIENT'S BODY. A 1.5MM X 20MM APEX BALLOON WAS USED TO STABILIZE THE ARTERY AND THE PATIENT WAS TAKEN TO BYPASS SURGERY. THE PATIENT'S STATUS WAS FAIRLY STABLE BEFORE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237029 APEX? PUSH CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493896112150

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention