BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY DETACHABLE COIL SYSTEM

    MDR report key: 2821125 · Received November 6, 2012

    Report

    Report Number
    3007628272-2012-50075
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 24, 2012
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLIZATION FOR COLLATERAL CIRCULATION BEFORE FONTAN SURGERY THAT WAS NOT CALCIFIED AND NOT TORTUOUS. ACCESS WAS OBTAINED FROM RIGHT FEMORAL ARTERY. IT WAS NOTED THAT WHILE ADVANCING AN ORBIT GALAXY (640CF0925/13500493, COMPLAINT PRODUCT) IN A PROWLER SELECT PLUS (606-S255X/15664103, COMPLAINT PRODUCT), THE ORBIT GALAXY GOT STUCK AROUND THE PROXIMAL SECTION OF THE PROWLER SELECT PLUS. BOTH THE ORBIT GALAXY AND THE PROWLER SELECT PLUS WERE SAFELY REMOVED AS A UNIT FROM THE PATIENT AND WERE REPLACED FOR THE SAME PRODUCTS (LOT UNKNOWN). HOWEVER, AFTER WITHDRAWAL, WHEN THE PHYSICIAN PULLED THE ORBIT GALAXY BACK FROM THE PROWLER SELECT PLUS, THE COIL OF THE ORBIT GALAXY WAS SEPARATED FROM THE DELIVERY TUBE. IT IS UNKNOWN WHERE AND WHEN EXACTLY IT HAD OCCURRED. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY OTHER ISSUES. NO PATIENT INJURY WAS REPORTED. THE COMPLAINT PRODUCTS WERE NEW AND WERE STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE COIL BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. THE COMPLAINT PRODUCTS ARE GOING TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORBIT GALAXY DETACHABLE COIL SYSTEM ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA 13500493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PROWLER SELECT PLUS MICROCATHETER LOT 15664103.| PROWLER SELECT PLUS MICROCATHETER: LOT 15664103