BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3953845 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04418
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 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. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER WITH NO OTHER DEVICES. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON AND BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS LOOSELY FOLDED. THERE WERE MULTIPLE KINKS THROUGHOUT THE SHAFT; WITH MAJORITY OF THEM 3CM ¿ 4.5CM PROXIMAL OF THE BI-COMPONENT WELD. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE INNER DIAMETER (ID) OF THE CATHETER WAS MEASURED AT EXIT NOTCH AND DISTAL TIP WITH A CALIBRATED PIN GAUGE SET, WHICH IS WITHIN THE NC QUANTUM APEX SPECIFICATIONS. THE GUIDEWIRE USED IN THE PROCEDURE WAS NOT RECEIVED WITH THIS DEVICE. A .014¿ KINETIX GUIDEWIRE WAS USED FOR FUNCTIONAL TESTING. THE OUTER DIAMETER (OD) OF THE KINETIX GUIDEWIRE WAS MEASURED USING A CALIBRATED SNAP GAUGE. FUNCTIONAL TESTING WAS PERFORMED BY LOADING THE GUIDEWIRE INTO THE TIP AND EXIT NOTCH. THE GUIDEWIRE WAS ABLE TO BE ADVANCED THROUGH THE ENTIRE LENGTH OF THE INNER SHAFT BOTH TIMES WITH SLIGHT RESISTANCE AT THE KINKS. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE KINKS OR THE REPORTED CATHETER FROZE ON THE GUIDEWIRE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDE WIRE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL END OF THE LEFT CIRCUMFLEX ARTERY. THE 15MM X 2.50MM NC QUANTUM APEX¿ BALLOON CATHETER WAS ADVANCED TO THE LESION VIA A NON BSC GUIDE WIRE HOWEVER FRICTION WAS ENCOUNTERED UPON INFLATION OF THE BALLOON. THE BALLOON CATHETER WAS STUCK ON THE WIRE AND WAS UNABLE TO BE REMOVED. THE DEVICE WAS REMOVED TOGETHER WITH THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431455 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415250 16289893

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION BLUD/ ASHI INTECH