BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 4915268 · Received July 15, 2015

    Report

    Report Number
    2134265-2015-04520
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 19, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2015-04519. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). ENGAGEMENT OF THE LEFT MAIN TRUNK (LMT) WAS DONE WITH EASE USING A 6F 3.5 NON-BSC GUIDE CATHETER. WIRING OF THE DISTAL PART OF THE LAD WAS DONE WITH A 0.014 NON-BSC GUIDEWIRE. INITIAL DILATION WAS PERFORMED WITH A 2.0MM NON-BSC BALLOON CATHETER FOLLOWED BY A 15MM X 2.25MM NC QUANTUM APEX¿; HOWEVER, THE 15MM X 2.25MM NC QUANTUM APEX¿ BALLOON RUPTURED UPON THE THIRD INFLATION AT 20 ATMOSPHERES. THE RUPTURED 15MM X 2.25MM NC QUANTUM APEX¿ BALLOON CATHETER WAS COMPLETELY REMOVED AND WAS EXCHANGED WITH ANOTHER 15MM X 2.50MM NC QUANTUM APEX¿ BALLOON CATHETER; HOWEVER, THE 15MM X 2.50MM NC QUANTUM APEX¿ BALLOON ALSO RUPTURED UPON THE FOURTH INFLATION AT 20 ATMOSPHERES. THE BALLOON WAS COMPLETELY REMOVED. AN ATTEMPT WAS MADE TO ADVANCE A 2.5X28MM AND A 2.25X38MM SYNERGY STENTS SEVERAL TIMES BUT THEY COULD NOT PASS THE MID LAD. THE PHYSICIAN TRIED A 2.50X15MM NON-BSC BALLOON CATHETER THEN TRIED A 2.25X38MM SYNERGY STENT AGAIN BUT STILL COULD NOT PASS THE LESION. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE AT THIS TIME. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE, NO CHEST PAIN AND WITH GOOD VITAL SIGNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459294 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415250 17150733

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR XB3.5,6F GUIDE CATHETER| 15MM X 2.50MM NC QUANTUM APEX¿ BALLOON CATHETER| SION BLUE GUIDEWIRE