BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1003209 · Received February 25, 2008

    Report

    Report Number
    1317056-2008-00011
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 2008
    Manufacturer
    NAMIC/VA
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE 2007 COMPLAINT REPORT FOR THE CONTRAST INJECTION LINE PRODUCT FAMILY DID NOT NOTE ANY ADVERSE TRENDS FOR THE FAILURE MODE OF "FITTING DETACHED." AS NO SAMPLE IS BEING RETURNED FOR ANALYSIS, WE ARE UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS INCIDENT, HOWEVER, THE PROCESS CONTROLS IN PLACE FOR THIS PRODUCT ARE CONSIDERED ADEQUATE TO DETECT THIS REPORTED FAILURE MODE. THE CONTROLS ARE AS FOLLOWS: THE FEMALE FITTING IS INSERT MOLDED ONTO THE LINE WITH PROCEDURES REQUIRING A 100% VISUAL INSPECTION FOR MOLDING DEFECTS AND AN IN-PROCESS INSPECTION INCLUDING VISUAL, TAPER, AND THREAD DIMENSIONAL INSPECTION. THE ROTATING MALE ADAPTOR STEM CUP IS INSERT MOLDED ONTO THE LINE WITH PROCEDURES REQUIRING A 100% VISUAL INSPECTION INCLUDING VISUAL AND DIMENSIONAL INSPECTIONS. THE ROTATING ADAPTOR IS SWAGED ONTO THE LINE WITH PROCEDURES REQUIRING A 100% INSPECTION AND 5 PIECE LEAK TEST AND TORQUE TEST EVERY HOUR. ADDITIONALLY, AN AQL INSPECTION IS PERFORMED IN PROCESS BY QUALITY ASSURANCE FOR VISUAL, DIMENSIONAL, SWAGE CHECK, AND LEAK TESTING.

    Description of Event or Problem · 1

    AS REPORTED BY CUSTOMER, DURING A CARDIAC CATH LAB PROCEDURE, LAB PERSONNEL HAD JUST ASPIRATED BACK FROM THEIR FIRST MEDRAD POWER INJECTION AND WERE GETTING READY TO INJECT AGAIN. ATTACHED TO THE MEDRAD WAS A NAMIC/VA HIGH PRESSURE CONTRAST INJECTION LINE. THEY WERE INJECTING 30-35CC'S OF CONTRAST AT 600PSI, WHEN THE LINE "BURST AT THE CONNECTOR," CAUSING WASTE AND CONTRAST TO BE SPLATTERED ALL OVER THE ROOM AND THE TECHNICIANS. THERE WAS NO AIR INJECTED INTO THE PT AND NO PT COMPLICATIONS. THE LINE WAS DISPOSED OF AT THE HOSP AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC HIGH PRESSURE CONTRAST INJECTION LINE DXT NAMIC/VA NA 1238020

    Patients

    Seq Age Sex Outcome Treatment
    1