BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3912415 · Received July 3, 2014

    Report

    Report Number
    2134265-2014-03816
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR; VISUAL AND TACTILE INSPECTION WAS PERFORMED. THERE WAS BLOOD AND CONTRAST IN THE INFLATION LUMEN AND THE BALLOON WAS TIGHTLY WRAPPED. THE HYPOTUBE WAS KINKED AND BENT IN NUMEROUS PLACES AND BROKEN 68.5CM FROM THE STRAIN RELIEF. THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. EXAMINATION UNDER MAGNIFICATION REVEALED THAT SHAFT KINKS 6.5CM AND 19.5CM FROM THE DISTAL TIP. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY(LAD). A 15MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED TO TREAT THE LESION AND UPON INSERTION ON THE GUIDEWIRE, THE MIDDLE PART OF THE CATHETER SHAFT BROKE. THE DEVICE WAS RETRACTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY(LAD). A 15MM X 2.75MM NC QUANTUM APEX¿ BALLOON CATHETER WAS SELECTED TO TREAT THE LESION AND UPON INSERTION ON THE GUIDEWIRE, THE MIDDLE PART OF THE CATHETER SHAFT BROKE. THE DEVICE WAS RETRACTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391042 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415270 16893094

    Patients

    Seq Age Sex Outcome Treatment
    1