BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 3072750 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02486
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    SAME CASE AS (B)(4). IT WAS REPORTED THAT DURING A ANGIOPLASTY AND STENTING TREATMENT PROCEDURE, A BALLOON DEFLATION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL PERONEAL TRUNK OF THE LEFT LEG. A 12MM X 5.00MM NC QUANTUM APEX BALLOON CATHETER WAS USED TO DILATE AN UNSPECIFIED STENT AT 20ATMS. HOWEVER, THE BALLOON WOULD NOT DEFLATE. PHYSICIAN ATTEMPT TO PULL THE NC QUANTUM APEX BALLOON CATHETER INTO THE 6FR SHEATH WAS UNSUCCESSFUL AS THE DISTAL 33% OF THE BALLOON REMAINED INFLATED AND WOULD NOT FIT INTO THE SHEATH. AS A RESULT, THE NC QUANTUM APEX BALLOON CATHETER AND THE INTRODUCER SHEATH HAD TO BE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175415 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412500 15502317

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR