BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1961413 · Received January 14, 2011

    Report

    Report Number
    2134265-2010-05895
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER:THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE (CIS) FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW FOR THE REPORTED BATCH NUMBER CONFIRMED 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 CORONARY ARTERY STENTING TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS A DE NOVO LESION THAT WAS 50% STENOSED, MODERATELY TORTUOUS CALCIFIED LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN WAS USING A STERLING BALLOON CATHETER. THE BALLOON RUPTURED AT THE 1ST INFLATION AT 4ATMS. THE PATIENT WAS A SYMPTOMATIC. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT CONDITION IS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031654010 13506984

    Patients

    Seq Age Sex Outcome Treatment
    1