BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3890976 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03679
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN NC QUANTUM APEX BALLOON CATHETER. THERE WAS BLOOD IN THE INFLATION LUMEN AND GUIDEWIRE LUMEN. THE DEVICE WAS RETURNED IN TWO (2) PIECES. THE CATHETER WAS VISUALLY AND TACTILELY INSPECTED. THERE WERE MULTIPLE HYPOTUBE KINKS AND THE HYPOTUBE WAS BROKEN 83CM FROM THE STRAIN RELIEF. THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THE SHAFT WAS KINKED 26.5CM FROM THE DISTAL TIP. THE CATHETER WAS INSPECTED UNDER MAGNIFICATION; THE DISTAL TIP WAS DAMAGED BUT THERE WAS NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURED. A 15MM X 4.00MM NC QUANTUM APEX¿ BALLOON CATHETER WAS SELECTED FOR THE PROCEDURE, HOWEVER THE SHAFT OF THE CATHETER WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURED. A 15MM X 4.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR THE PROCEDURE, HOWEVER THE SHAFT OF THE CATHETER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367466 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415400 16726298

    Patients

    Seq Age Sex Outcome Treatment
    1