BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY DETACHABLE COIL SYSTEM

    MDR report key: 2823342 · Received November 7, 2012

    Report

    Report Number
    3007628272-2012-50076
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Removal / Correction Number
    1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    NOTE: WITH THE REVIEW OF ADDITIONAL INFORMATION THE POTENTIAL FOR INJURY ASSOCIATED WITH THE REPORTED EVENT IS REMOTE; THEREFORE, THIS DOES NOT MEET THE REQUIREMENTS FOR A REPORTABLE EVENT. ADDITIONALLY, NO FURTHER REPORTS WILL BE FORTHCOMING FOR THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLIZATION FOR MAJOR AORTOPULMONARY COLLATERAL ARTERY (MAPCA). CHARACTERISTICS OF THE VESSEL WERE NOT PROVIDED. DURING THE PROCEDURE, WHILE ADVANCING AN ORBIT GALAXY(640CF0412/15592764, COMPLAINT PRODUCT) IN A TURBO TRACKER (DETAILS UNKNOWN/STRYKER), THERE WAS SEVERE RESISTANCE AROUND 70CM FROM THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN COULD NOT PUSH THE COIL ANY FURTHER. HE FIRSTLY WITHDREW AND FLASHED BOTH THE ORBIT GALAXY AND THE MICROCATHETER WITH SALINE AND RE-INSERTED THE SAME ORBIT GALAXY AND THE SAME MICROCATHETER, BUT HE STILL EXPERIENCED SEVERE RESISTANCE. THEN, THE MICROCATHETER WAS REPLACED FOR A NEW PRODUCT OF THE SAME TYPE, BUT THE SITUATION WAS THE SAME. THE ORBIT GALAXY WAS SAFELY REMOVED FROM THE PATIENT AND WAS REPLACED FOR A COMPETITOR'S PRODUCT (IDC/BOSTON SCIENTIFIC, DETAILS UNKNOWN), WHICH WAS SUCCESSFULLY PLACED IN THE TARGET VESSEL USING THE 2ND MICROCATHETER. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND WAS 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 PRODUCT BY VISUAL INSPECTION. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT IS 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 15592764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN TURBO TRACKER MICROCATHETER