BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1MM X 4CM

    MDR report key: 8817105 · Received July 23, 2019

    Report

    Report Number
    3008114965-2019-01096
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    May 14, 2019
    Report Date
    May 14, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080251
    PMA / PMN Number
    K000715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS NOTED STRETCHED. THE FINDINGS MEET FDA REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. (B)(6). MANUFACTURING SITE NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2019-01097. COMPLAINT CONCLUSION AS REPORTED BY AN HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A MAJOR AORTOPULMONARY COLLATERAL ARTERY (MAPCA) A 1MMX4CM GALAXY G3 (GLM910040, L14125) AND A 2MMX6CM (GLM920060, L14602) WERE INSERTED INTO THE MICROCATHETER, BUT THERE WAS RESISTANCE FELT BETWEEN THE MICROCATHETER AND THE COILS AND THEY BOTH BECAME ¿STUCK¿. THEREFORE, THE COMPLIANT COILS WERE REPLACED WITH NEW COILS AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED. THE DEVICES WERE USED, PREPPED AND HANDLED PER THE INSTRUCTIONS FIR USE (IFU). INITIALLY, THE TARGET LESION WAS THE COLLATERAL CIRCULATION THAT ORIGINATES FROM THE INTERNAL THORACIC ARTERY. THE CONCOMITANT MICROCATHETER AND THE GUIDING CATHETER MADE AN APPROACH AND THE COILING STARTED. NO EXCESSIVE FORCE WAS USED AT ANY TIME. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. A PROWLER SELECT PLUS AND LIGHTHOUSE MICROCATHETERS WERE USED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS NOTED TO BE STRETCHED. A NON-STERILE UNIT GALAXY G3 MINI 1MM X 4CM WAS RECEIVED INSIDE OF A POUCH. THE HUB WAS INSPECTED, AND NO DAMAGES WAS NOTED ON IT. THE DPU WAS INSPECTED AND IT WAS FOUND IN GOOD NORMAL CONDITIONS. THE INTRODUCER WAS INSPECTED, AND IT WAS FOUND PARTIALLY UNZIPPED AND KINKED. THE RE-SHEATING TOOL WAS FOUND WITHOUT DAMAGE. ALSO, THE MARKER BAND WAS FOUND AT 39CM FROM HUB, AND IT WAS FOUND WITHIN SPECIFICATION. THE V-NOTCH WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND IN NORMAL GOOD CONDITION. THE RH WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND NO HEATED AND IN GOOD CONDITIONS INSIDE THE INTRODUCER. THE EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND PROTRUDED FROM THE INTRODUCER AND IT WAS FOUND STRETCHED. COULD NOT BE EVALUATED DUE THE KINKED CONDITION NOTED ON THE INTRODUCER AND THE STRETCHED/PROTRUDED CONDITION NOTED ON THE EMBOLIC COIL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE L14125 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE COMPLAINT REPORTED BY THE CUSTOMER ¿COIL ¿ RESISTANCE/FRICTION-WITH INTRODUCER¿ COULD NOT BE EVALUATED DUE THE STRETCHED/PROTRUDED CONDITION NOTED ON THE EMBOLIC COIL. THE CONDITION (KINKED) OBSERVED ON THE INTRODUCER AND THE STRETCHED CONDITION NOTED ON THE EMBOLIC COIL MAY HAVE CONTRIBUTED TO THE FAILURE AND APPEAR TO HAVE BEEN CAUSED BY EXCESSIVE FORCE BEING APPLIED TO THE DEVICE HOWEVER NONE OF THOSE CAN BE CONCLUSIVELY DETERMINED. 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 DETERMINED; HOWEVER, THERE ARE CIRCUMSTANCES OF THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE IFU, STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE, AND ALSO INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE RESISTANCE. THE IFU GIVES INSTRUCTIONS FOR WHEN RESISTANCE IS FELT DURING DELIVERY OF THE DEVICE. 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 AN HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A MAJOR AORTOPULMONARY COLLATERAL ARTERY (MAPCA) A 1MMX4CM GALAXY G3 (GLM910040, L14125) AND A 2MMX6CM (GLM920060, L14602) WERE INSERTED INTO THE MICROCATHETER, BUT THERE WAS RESISTANCE FELT BETWEEN THE MICROCATHETER AND THE COILS AND THEY BOTH BECAME ¿STUCK¿. THEREFORE, THE COMPLIANT COILS WERE REPLACED WITH NEW COILS AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED. THE DEVICES WERE USED, PREPPED AND HANDLED PER THE INSTRUCTIONS FIR USE (IFU). INITIALLY, THE TARGET LESION WAS THE COLLATERAL CIRCULATION THAT ORIGINATES FROM THE INTERNAL THORACIC ARTERY. THE CONCOMITANT MICROCATHETER AND THE GUIDING CATHETER MADE AN APPROACH AND THE COILING STARTED. NO EXCESSIVE FORCE WAS USED AT ANY TIME. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. A PROWLER SELECT PLUS AND LIGHTHOUSE MICROCATHETERS WERE USED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS NOTED TO BE STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609241 GALAXY G3 MINI 1MM X 4CM GALAXY G3 KRD MEDOS INTERNATIONAL SARL L14125 10886704080251

    Patients

    Seq Age Sex Outcome Treatment
    1 LIGHTHOUSE MICROCATHETER| UNKPROWLERSELECT