BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 XSFT 2.5MM X 3.5CM

    MDR report key: 9224004 · Received October 23, 2019

    Report

    Report Number
    3008114965-2019-01211
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    September 30, 2019
    Report Date
    October 1, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077619
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT ACA, DURING ADVANCEMENT THROUGH A RESTER MICROCATHETER (MC), THERE WAS RESISTANCE WITH A 2.5MM X 3.5CM GALAXY G3 XSFT COIL (GLX122535, L13257). THE COMPLAINT COIL WAS USED AS THE FIRST COIL. THE PHYSICIAN ATTEMPTED TO PULL OUT THE COIL DELIVERY SYSTEM, BUT IT PREMATURELY DETACHED. THE COMPLAINT COIL WAS REMOVED WITH THE MC AND A COMPETITIVE COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE COIL. THERE WAS NO CLINICALLY SIGNIFICANT PROLONGATION IN THE PROCEDURE DUE TO THE EVENT. THE DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE (IFU). NO DAMAGES WERE CONFIRMED PRIOR TO USE. ADEQUATE FLUSH HAD BEEN MAINTAINED THROUGH THE DEVICES. NO EXCESSIVE FORCE HAD BEEN USED WITH THE DEVICE. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE L13257 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT OF ¿COIL PREMATURE ¿COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT DEVICES; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE AND VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. MANUFACTURING SITE NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). INITIAL REPORTER PHONE: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT ACA, DURING ADVANCEMENT THROUGH A RESTER MICROCATHETER (MC), THERE WAS RESISTANCE WITH A 2.5MM X 3.5CM GALAXY G3 XSFT COIL (GLX122535, L13257). THE COMPLAINT COIL WAS USED AS THE FIRST COIL. THE PHYSICIAN ATTEMPTED TO PULL OUT THE COIL DELIVERY SYSTEM, BUT IT PREMATURELY DETACHED. THE COMPLAINT COIL WAS REMOVED WITH THE MC AND A COMPETITIVE COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE COIL. THERE WAS NO CLINICALLY SIGNIFICANT PROLONGATION IN THE PROCEDURE DUE TO THE EVENT. THE DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE (IFU). NO DAMAGES WERE CONFIRMED PRIOR TO USE. ADEQUATE FLUSH HAD BEEN MAINTAINED THROUGH THE DEVICES. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018625 GALAXY G3 XSFT 2.5MM X 3.5CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL L13257 10886704077619

    Patients

    Seq Age Sex Outcome Treatment
    1 RESTER MICROCATHETER.