BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3242326 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04981
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 24, 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 COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (RCA). A 6F NON-BSC INTRODUCER SHEATH FOLLOWED BY A NON-BSC GUIDE WIRE THEN A 6F NON-BSC GUIDING CATHETER WAS USED TO ENTER THE LESION. AN ATLANTIS IVUS CATHETER WAS USED BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THOUGHT THE IVUS WAS ABLE TO CROSS THE LESION. A 8 MM X 3.00 MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR DILATION. THE COMPLAINT DEVICE WAS INFLATED TWICE, 1ST DILATION IS AT 18 ATM, HOWEVER, THE INDENTATION WAS NOT PERFORMED ENOUGH DUE TO THE SEVERE CALCIFIED LESION AND ON THE 2ND DILATION IT RUPTURED AT 18 ATM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343097 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408300 15746052

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: SION| GUIDING CATHETER: 6F ACCESS JR4| INTRODUCER SHEATH: 6F RADIFOCUS