BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 XSFT HEL 2MM X 8CM

    MDR report key: 10337945 · Received July 29, 2020

    Report

    Report Number
    3008114965-2020-00308
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 10, 2020
    Report Date
    July 10, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077763
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED BY THE FILED, DURING A COIL TO THE AORTOPULMONARY COLLATERAL ARTERIES (APCA), A 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208, K10196) WAS USED AS THE THIRD COIL BUT IT WAS NOT ABLE TO BE DETACHED. THE POWER LUMP ILLUMINATED DURING A PRE DETACHMENT ELECTRICAL CHECK, HOWEVER FAILED TO DETACH INSIDE THE PATIENT. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO PROCEDURE PROLONGATION DUE TO THE EVENT. THE SAME DETACHABLE CONTROL BOX AND CABLE WERE USED WITH PRIOR COILS. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICES K10196 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 ¿ FAILURE TO DETACH¿ 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. FAILURE TO DETACH IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) CONTAINS SEVERAL PRECAUTIONS RELATED TO THIS ISSUE AND INCLUDES INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE FILED, DURING A COIL TO THE AORTOPULMONARY COLLATERAL ARTERIES (APCA), A 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208, K10196) WAS USED AS THE THIRD COIL BUT IT WAS NOT ABLE TO BE DETACHED. THE POWER LUMP ILLUMINATED DURING A PRE DETACHMENT ELECTRICAL CHECK, HOWEVER FAILED TO DETACH INSIDE THE PATIENT. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO PROCEDURE PROLONGATION DUE TO THE EVENT. THE SAME DETACHABLE CONTROL BOX AND CABLE WERE USED WITH PRIOR COILS. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805157 GALAXY G3 XSFT HEL 2MM X 8CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLX120208 K10196 10886704077763

    Patients

    Seq Age Sex Outcome Treatment
    1