BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2181455 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-03029
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX ARTERY. THE 15MM X 2.50MM NC QUANTUM APEX BALLOON WAS USED FOR POST-DILATATION FOLLOWING PARTIAL EXPANSION OF AN UNKNOWN STENT. THE NC QUANTUM APEX WAS INFLATED SEVERAL TIMES AT 18ATMS. DUE TO THE STENT NOT EXPANDING ENOUGH, THE NC QUANTUM APEX WAS INFLATED TO 20ATMS WHEN THE BALLOON RUPTURE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURERS BALLOON DEVICE. 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 H7493912415250 13728617

    Patients

    Seq Age Sex Outcome Treatment
    1