BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM

    MDR report key: 6135794 · Received November 30, 2016

    Report

    Report Number
    2954740-2016-00290
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    August 25, 2016
    Report Date
    September 1, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    10878528009471
    PMA / PMN Number
    K120686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE INITIAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 2954740-2016-00290. THIS EVENT BECAME MDR REPORTABLE ON 11NOV2016 UPON RECEIVING ADDITIONAL INFORMATION FROM REPORTER. ADDITIONAL PROCODE: KRD. (B)(4). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. NO CONCLUSIONS ARE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS IS FOLLOW-UP MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 2954740-2016-00290. BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY HEALTH CARE PROFESSIONAL, DURING A PROCEDURE ORBIT GALAXY, CATALOG# 641CF0306, LOT# P10635 ¿ DID NOT DETACH AND ORBIT GALAXY, CATALOG# 64HX0204, LOT# P11693 ¿ DID NOT STRIP. THERE WERE NO ADVERSE EVENTS REPORTED. PATIENT INFORMATION AND PROCEDURE DETAILS ARE UNKNOWN. IT WAS INITIALLY REPORTED THAT THE COMPLAINT DEVICES ARE AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787437 ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA P10635 10878528009471

    Patients

    Seq Age Sex Outcome Treatment
    1