BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 6MM X 15CM

    MDR report key: 9115379 · Received September 25, 2019

    Report

    Report Number
    3008114965-2019-01180
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 5, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077534
    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). SECTION B5: EVENT: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE GREEN FULL BATTERY LIGHT WAS ILLUMINATED AFTER PRESSING THE POWER BUTTON. ALSO, THE SYSTEM READY LIGHT WAS ILLUMINATED AFTER CONNECTING DCB, CABLE, AND MICRO COIL SYSTEM. HOWEVER, THE SYSTEM FAULT LIGHT WAS ILLUMINATED WHEN THE SURGEON PRESSED THE DETACH BUTTON, AND THE MICRO COIL COULD NOT BE DETACHED. (THE CONDITION OF THE DCB WAS PHOTOGRAPHED BY DISTRIBUTER WHO WAS PRESENT AT THAT MOMENT). THE SURGEON AND THE DISTRIBUTOR CHECKED THE CONNECTION, AND ALL WERE TIGHTLY CONNECTED. THE MICRO COIL SYSTEM WAS REMOVED FROM THE PATIENT. THE SURGEON PRESSED THE DETACH BUTTON TO CHECK THE DEVICE CONDITION OUTSIDE OF THE PATIENT BODY, AND THE MICRO COIL WAS DETACHED THIS TIME. SECTION E1 ¿ 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM (UNKNOWN SITE), A 6MM X 15CM GALAXY G3 (GLY120615, L12845) WAS BEING USED AS A FIRST FRAMING COIL AND ATTEMPTED TO BE DETACHED FOR IMPLANT IN THE TARGET LESION. THE GREEN SYSTEM READY LIGHT OF THE ENPOWER DETACHABLE CONTROL BOX 2 (DCB2000500, C46054) ILLUMINATED GREEN. HOWEVER, WHEN THE DETACHMENT BUTTON WAS PRESSED, THE GREEN SYSTEM READY LIGHT ILLUMINATED RED, AND COIL DID NOT DETACH. THE COMPLAINT COIL WAS REMOVED. THERE WAS NO PATIENT INJURY REPORTED. AN ENPOWER CONTROL CABLE (ECB00018200, L15918) WAS ALSO USED IN THIS CASE. PRELIMINARY PICTURES OF THE DCB, CONTROL CABLE AND MICROCOIL WERE RECEIVED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE GREEN FULL BATTERY LIGHT WAS ILLUMINATED AFTER PRESSING THE POWER BUTTON. ALSO, THE SYSTEM READY LIGHT WAS ILLUMINATED AFTER CONNECTING DCB, CABLE, AND MICRO COIL SYSTEM. HOWEVER, THE SYSTEM FAULT LIGHT WAS ILLUMINATED WHEN THE SURGEON PRESSED THE DETACH BUTTON, AND THE MICRO COIL COULD NOT BE DETACHED. THE CONDITION OF THE DCB WAS PHOTOGRAPHED BY DISTRIBUTER WHO WAS PRESENT AT THAT MOMENT. THE SURGEON AND THE DISTRIBUTOR CHECKED THE CONNECTION, AND ALL WERE TIGHTLY CONNECTED. THE MICRO COIL SYSTEM WAS REMOVED FROM THE PATIENT. THE SURGEON PRESSED THE DETACH BUTTON TO CHECK THE DEVICE CONDITION OUTSIDE OF THE PATIENT BODY, AND THE MICRO COIL WAS DETACHED THIS TIME. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND THEREFORE NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE L12845 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE PRELIMINARY PHOTOS FROM DCB, CONTROL CABLE AND MICROCOIL WERE RECEIVED. THE DCB, CONTROL CABLE AND MICROCOIL LOOK NORMAL WITH NO ANOMALIES. 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 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 AGE/DATE OF BIRTH, GENDER, WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. INITIAL REPORTER: THE CUSTOMER CONTACT INFORMATION, INCLUDING OCCUPATION, PHONE, AND FAX, WAS NOT REPORTED. MANUFACTURING SITE NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. PHOTO ANALYSIS: PRELIMINARY PHOTOS FROM DCB, CONTROL CABLE AND MICROCOIL WERE RECEIVED. DCB, CONTROL CABLE AND MICROCOIL LOOK NORMAL WITH NO ANOMALIES. BASED ON PROVIDED PHOTOS, THE ISSUE COULD NOT BE CONFIRMED, A FUNCTIONAL TEST WILL BE PERFORMED ONCE THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANEURYSM (UNKNOWN SITE), A 6MM X 15CM GALAXY G3 (GLY120615, L12845) WAS BEING USED AS A FIRST FRAMING COIL AND ATTEMPTED TO BE DETACHED FOR IMPLANT IN THE TARGET LESION. THE GREEN SYSTEM READY LIGHT OF THE ENPOWER DETACHABLE CONTROL BOX 2 (DCB2000500, C46054 ILLUMINATED GREEN. HOWEVER, WHEN THE DETACHMENT BUTTON WAS PRESSED, THE GREEN SYSTEM READY LIGHT ILLUMINATED RED, AND COIL DID NOT DETACH. THE COMPLAINT COIL WAS REMOVED. THERE WAS NO PATIENT INJURY REPORTED. AN ENPOWER CONTROL CABLE (ECB00018200, L15918) WAS ALSO USED IN THIS CASE. PRELIMINARY PICTURES OF THE DCB, CONTROL CABLE AND MICROCOIL WERE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911846 GALAXY G3 6MM X 15CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL L12845 10886704077534

    Patients

    Seq Age Sex Outcome Treatment
    1 ENPOWER CONTROL CABLE| ENPOWER DCB 2