BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2990530 · Received March 5, 2013

    Report

    Report Number
    2134265-2013-01528
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER CROSSING THE LESION WITH A 5.00 X 8 MM NC QUANTUM APEX BALLOON, THE DEVICE WAS INFLATED. DURING INFLATION THE BALLOON RUPTURED AT 20 ATMS. IT IS UNKNOWN HOW MANY INFLATIONS WERE PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93621 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408500 15673351

    Patients

    Seq Age Sex Outcome Treatment
    1