BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1951071 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05854
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. ACCESS WAS GAINED THROUGH THE LEFT FEMORAL ARTERY. THE LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS, SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA) WITH A 90 DEGREE BEND. THE PHYSICIAN HAD USED THE 3.25X12MM NC QUANTUM APEX BALLOON 3 TIMES DURING THE PROCEDURE WITH ALL INFLATIONS BEING SUCCESSFUL. ON THE 4TH USE OF THE DEVICE, DIFFICULTY CROSSING THE PREVIOUSLY PLACED 2.75X28MM PROMUS STENT WAS EXPERIENCED. THE BALLOON WAS INFLATED TO 16ATMS FOR 5-6 SECONDS WHEN A BALLOON RUPTURE OCCURRED INSIDE A PREVIOUSLY PLACED PROMUS STENT. ROTABLATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH A 3.25X15MM NON-BSC BALLOON. THE STENT REMAINS WELL APPOSED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912512320

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR GUIDELINER CATHETER| 6FR JR4 RUNWAY| MIRACLE BROTHERS 3 WIRE| 2.75X28MM PROMUS STENT