BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1812698 · Received August 24, 2010

    Report

    Report Number
    1058196-2010-00234
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 14100500 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS TESTING PER PROCEDURE. BASED ON THE REPORTED INFORMATION AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE REPORT THAT AIR REMAINED IN THE HUB OF THE ORBIT SYSTEM AFTER PURGING. WITH REVIEW OF THE MANUFACTURING RECORDS THERE ARE NO IDENTIFIED ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING PREP OF THE 4X10 MINI COMPLEX FILL ORBIT DELIVERY SYSTEM (637MF0410), AIR COULD NOT BE PURGED AND AIR REMAINED IN THE HUB OF THE PRODUCT. THE PROCEDURE WAS CONTINUED USING THE OTHER COILS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ALL THE PRODUCTS WERE STORED, HANDLE AND PREP PER LABELING INSTRUCTIONS. PRIOR TO CONNECTING AND DURING PREP, NEITHER THE SYRINGE NOR THE COIL DELIVERY SYSTEM WAS DAMAGED. AFTER DISCONNECTING THE COIL DELIVERY SYSTEM, NO DAMAGED WERE NOTED ON THE SYRINGE OR DELIVERY SYSTEM. DURING PREP, A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL AND PREP THE SYRINGE. THE SYRINGE WAS TAKING TO THE BLUE ZONE, AND THE BLUE ZONE WAS NOT EXCEEDED. PRIOR TO THIS COIL, ZONE# 3 AND THE ALTERNATE ZONE (RED) WERE NOT EXCEEDED. THE PRODUCT WAS CONNECTED PROPERLY TO THE HUB OF THE COIL DELIVERY SYSTEM, AND NO LEAKAGE WAS NOTED AT THE CONNECTOR, EXTENSION TUBING, DELIVERY SYSTEM HUB OR ANYWHERE ELSE. THE CONNECTOR WAS CHECKED FOR PROPER SEATING/FITTING ON THE DELIVERY SYSTEM HUB. AFTER THE PRODUCT FAILURE OCCURRED, NO OTHER DAMAGES WERE NOTED ON THE COIL (UNRAVELED/STRETCHED), DELIVERY SYSTEM, OR HUB, AND THE COIL WAS STILL ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 14100500

    Patients

    Seq Age Sex Outcome Treatment
    1 DCS SYRINGE.