BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 4863824 · Received June 23, 2015

    Report

    Report Number
    2134265-2015-03943
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR.: THE 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 FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% IN-STENT RESTENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED NON-BSC STENT PREVIOUSLY IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A FR 4.5 INTRODUCER SHEATH WAS PLACED. AFTER A NON-BSC GUIDE WIRE WAS ADVANCED TO CROSS THE LESION, A 4.0MMX20MMX143CM FG COYOTE NC MR (NC QUANTUM APEX¿) BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION; HOWEVER, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406122 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H74939282402010 16876590

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: PARENT4.5FR/MEDIKIT| GUIDEWIRE: COMMAND/AVJ