BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX

    MDR report key: 8201128 · Received December 27, 2018

    Report

    Report Number
    2134265-2018-64668
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    December 13, 2018
    Report Date
    December 27, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE 90% STENOSIS TARGET LESION WAS LOCATED IN THE MILD TORTUOSITY AND SEVERE CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.0MMX30MMX143CM COYOTE NC BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE 1ST INFLATION AT 6 ATMOSPHERE FOR 5 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039356 NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 24709 0022473200

    Patients

    Seq Age Sex Outcome Treatment
    1