BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2.5MM X 3.5CM

    MDR report key: 8087077 · Received November 19, 2018

    Report

    Report Number
    3008114965-2018-00796
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    November 4, 2018
    Report Date
    November 4, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    10886704080268
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO.: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE GALAXY G3 MINI 2.5MM X 3.5CM COIL (GLM925035 / L12395) WAS COMPLETELY ADVANCED INTO THE ANEURYSM AND THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DETACH THE COIL USING DIFFERENT POSITIONING STRATEGIES. THE GALAXY G3 MINI COIL EVENTUALLY DETACHED AND WAS IMPLANTED IN THE ANEURYSM AFTER AN APPROXIMATELY 7 ATTEMPTS WERE MADE. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT. BASED ON COMPLAINT INFORMATION, THE GALAXY G3 MINI 2.5MM X 3.5CM COIL REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR RETURN. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L12395) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT THAT THE GALAXY G3 MINI 2.5MM X 3.5CM COIL HAD SOME DIFFICULTY WITH DETACHMENT WHEN IT WAS ADVANCED INTO THE ANEURYSM COULD NOT BE CONFIRMED. THE COIL FINALLY DETACHED AND WAS IMPLANTED IN THE ANEURYSM. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND/OR DEVICE MANIPULATION/INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE GALAXY G3 MINI 2.5MM X 3.5CM COIL (GLM925035 / L12395) WAS COMPLETELY ADVANCED INTO THE ANEURYSM AND THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DETACH THE COIL USING DIFFERENT POSITIONING STRATEGIES. THE GALAXY G3 MINI COIL EVENTUALLY DETACHED AND WAS IMPLANTED IN THE ANEURYSM AFTER AN APPROXIMATELY 7 ATTEMPTS WERE MADE. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924305 GALAXY G3 MINI 2.5MM X 3.5CM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD SEE H.10 L12395 10886704080268

    Patients

    Seq Age Sex Outcome Treatment
    1