BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2.5MM X 4.5CM

    MDR report key: 11090068 · Received December 29, 2020

    Report

    Report Number
    3008114965-2020-00585
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 13, 2020
    Report Date
    December 13, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080275
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED BY CERENOVUS PRODUCT ANALYSIS LAB ON 1/15/2021. THE RETURNED PRODUCT UNDERWENT EVALUATION AND ANALYSIS. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WITH THE TARGET VESSEL BEING THE INTERNAL CAROTID ARTERY (ICA), THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / L15582) WAS INSERTED INTO THE TARGET LESION THEN AN ATTEMPT TO DETACH THE COIL WAS MADE WITH THE ENPOWER CONTROL CABLE (ECB00018200 / K10545) PER THE INSTRUCTIONS FOR USE (IFU). THE GREEN SYSTEM READY LIGHT WAS ILLUMINATED, AND THE AUDIBLE BEEP SIGNAL WAS HEARD. HOWEVER, THE COMPLAINT COIL DID NOT DETACH. THE ENPOWER CONTROL CABLE WAS REPLACED WITH ANOTHER CABLE, BUT THE SAME ISSUE OCCURRED. THE COMPLAINT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER COIL; THE REPLACEMENT COIL WAS DETACHED WITH THE REPLACEMENT CABLE WITHOUT ANY ISSUE. THE REPORTED EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT PROCEDURE DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR INJURY. THE RETURNED DEVICE UNDERWENT EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 2.50MM X 4.50CM GALAXY G3 MINI COIL WAS RECEIVED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE DEVICE WAS OBSERVED TO BE IN GOOD, NORMAL CONDITION. THE EMBOLIC COIL WAS NOT RETURNED WITH THE REST OF THE DEVICE. THE MARKER BAND WAS FOUND AT 39CM FROM THE HUB; THIS IS WITHIN SPECIFICATION. MICROSCOPIC INSPECTION WAS PERFORMED ON THE DEVICE; THE RESISTANCE HEATING (RH) COIL SHOWED EVIDENCE THAT IT HAD BEEN HEATED. THE EMBOLIC COIL WAS NOT RETURNED. FUNCTIONAL TESTING COULD NOT BE CONDUCTED AS THE EMBOLIC COIL WAS ALREADY DETACHED FROM THE DEVICE AND NOT INCLUDED IN THE RETURN WITH THE REST OF THE DEVICE COMPONENTS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L15582) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE COMPLAINT REPORTED THAT DURING THE PROCEDURE WITH THE TARGET VESSEL BEING THE INTERNAL CAROTID ARTERY (ICA), THE 2.50MM X 4.50CM GALAXY G3 MINI COIL WAS INSERTED INTO THE TARGET LESION THEN AN ATTEMPT TO DETACH THE COIL WAS MADE WITH THE ENPOWER CONTROL CABLE PER THE IFU. THE GREEN SYSTEM READY LIGHT WAS ILLUMINATED, AND THE AUDIBLE BEEP SIGNAL WAS HEARD. HOWEVER, THE COMPLAINT COIL DID NOT DETACH. THE RETURNED DEVICE SHOWED EVIDENCE THAT THE DETACHMENT CYCLE HAD BEEN INITIATED AS REPORTED, HOWEVER, THE EMBOLIC COIL WAS NOT RETURNED. THERE WAS NO ANOMALY OR DAMAGE OBSERVED ON THE COMPONENTS OF THE DEVICE THAT WERE RETURNED. THE REPORTED ISSUE RELATED TO THE DEVICE FAILURE TO DETACH WAS NOT CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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.

    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. THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L15582) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. 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 WITH THE TARGET VESSEL BEING THE INTERNAL CAROTID ARTERY (ICA), THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / L15582) WAS INSERTED INTO THE TARGET LESION THEN AN ATTEMPT TO DETACH THE COIL WAS MADE WITH THE ENPOWER CONTROL CABLE (ECB00018200 / K10545) PER THE INSTRUCTIONS FOR USE (IFU). THE GREEN SYSTEM READY LIGHT WAS ILLUMINATED, AND THE AUDIBLE BEEP SIGNAL WAS HEARD. HOWEVER, THE COMPLAINT COIL DID NOT DETACH. THE ENPOWER CONTROL CABLE WAS REPLACED WITH ANOTHER CABLE, BUT THE SAME ISSUE OCCURRED. THE COMPLAINT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER COIL; THE REPLACEMENT COIL WAS DETACHED WITH THE REPLACEMENT CABLE WITHOUT ANY ISSUE. THE REPORTED EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT PROCEDURE DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556014 GALAXY G3 MINI 2.5MM X 4.5CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM925045 L15582 10886704080275

    Patients

    Seq Age Sex Outcome Treatment
    1 ENPOWER CONTROL CABLE