BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 MINI 2MM X 4CM

    MDR report key: 10737856 · Received October 26, 2020

    Report

    Report Number
    3008114965-2020-00458
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 7, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080305
    PMA / PMN Number
    K171862
    Adverse Event
    Yes
    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 IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 12/21/2020. [ADDITIONAL EVENT INFORMATION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENCY COIL EMBOLIZATION PROCEDURE WITH THE TARGET LESION LOCATED ON THE INTERIOR CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC), A 2MM X 4CM GALAXY G3 MINI (GLM920040 / K10501) WAS THE SEVENTH COIL USED, BUT A STRONG RESISTANCE WAS FELT BETWEEN THE COIL AND THE CONCOMITANT MICROCATHETER (UNKNOWN / UNSPECIFIED BRAND) DURING ADVANCEMENT AND THE COIL PARTIALLY PROTRUDED FROM THE TIP OF THE MICROCATHETER. IT WAS REPORTED THAT THERE WAS A POSSIBILITY THAT THE TAIL OF THE PREVIOUSLY PLACED SIXTH COIL (COMPETITOR PRODUCT) REMAINED AT THE TIP OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL, BUT THE COIL BECAME ENTANGLED WITH THE IMPLANTED COIL MASS. THE COIL WAS ULTIMATELY REMOVED FROM THE PATIENT. THE TAIL OF AN UNSPECIFIED COIL EVENTUALLY HERNIATED FROM THE NECK OF THE ANEURYSM, REQUIRING STENT IMPLANTATION. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE MICROCATHETER USED WITH THE COMPLAINT COIL WAS THE CONCOMITANT PHENOM¿ 17 MICROCATHETER (MEDTRONIC). THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE TIP OF THE COIL BECAME ENTANGLED WITH THE IMPLANTED COIL MASS, AS A RESULT, THE COMPLAINT COIL COULD NOT BE RESHEATHED. AN ATTEMPT WAS MADE TO REMOVE THE COIL WITH A SNARE, ¿WHICH MADE FORCE WITH THE WIRE¿ AND THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT¿S BODY. UNUSUAL RESISTANCE OR FRICTION DURING ADVANCEMENT AND ENTANGLEMENT WITH PREVIOUSLY PLACED COILS ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF EMBOLIC COILS IN ENDOVASCULAR EMBOLIZATION. THE GALAXY G3 MINI INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICROCOIL SYSTEM, EXAMINE FOR DAMAGE, AND REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS, WITHDRAW, AND EXAMINE THE DELIVERY CATHETER SYSTEM. IF THE MICROCOIL SYSTEM BECOMES IMMOBILE IN THE INFUSION MICROCATHETER, APPLY A GENTLE PUSH-PULL MOTION TO FREE IT. IF UNSUCCESSFUL, REMOVE BOTH MICROCATHETER AND MICROCOIL SYSTEM TOGETHER AS A UNIT AND REPLACE WITH NEW DEVICES. WITH THE AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING ANEURYSM / VESSEL CHARACTERISTICS, DEVICE INTERACTION, DEVICE SELECTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. PRODUCT COMPLAINT FOLLOW-UP IS NEEDED TO DETERMINE IF ADDITIONAL INTERVENTION WAS REQUIRED TO WITHDRAW THE ENTANGLED COMPLAINT COIL FROM THE PATIENT AND THE BRAND/MANUFACTURER OF COIL THAT PROTRUDED FROM THE NECK OF THE ANEURYSM PROMPTING STENT PLACEMENT. SINCE THE ALLEGED COIL ENTANGLEMENT ULTIMATELY REQUIRED ADDITIONAL INTERVENTION TO PRECLUDE PATIENT COMPLICATIONS, THE EVENT MEETS MDR REPORTING CRITERIA AS A ¿SERIOUS INJURY.¿ E.1: THE INITIAL REPORTER PHONE: (B)(6). UPDATED SECTIONS: CONCOMITANT PRODUCTS. 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

    (B)(4). PROCODE IS KRD/HCG. (B)(4). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENCY COIL EMBOLIZATION PROCEDURE WITH THE TARGET LESION LOCATED ON THE INTERIOR CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC), A 2MM X 4CM GALAXY G3 MINI (GLM920040 / K10501) WAS THE SEVENTH COIL USED, BUT A STRONG RESISTANCE WAS FELT BETWEEN THE COIL AND THE CONCOMITANT MICROCATHETER (UNKNOWN / UNSPECIFIED BRAND) DURING ADVANCEMENT AND THE COIL PARTIALLY PROTRUDED FROM THE TIP OF THE MICROCATHETER. IT WAS REPORTED THAT THERE WAS A POSSIBILITY THAT THE TAIL OF THE PREVIOUSLY PLACED SIXTH COIL (COMPETITOR PRODUCT) REMAINED AT THE TIP OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL, BUT THE COIL BECAME ENTANGLED WITH THE IMPLANTED COIL MASS. THE COIL WAS ULTIMATELY REMOVED FROM THE PATIENT. THE TAIL OF AN UNSPECIFIED COIL EVENTUALLY HERNIATED FROM THE NECK OF THE ANEURYSM, REQUIRING STENT IMPLANTATION. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10501) 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. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. UNUSUAL RESISTANCE OR FRICTION DURING ADVANCEMENT AND ENTANGLEMENT WITH PREVIOUSLY PLACED COILS ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF EMBOLIC COILS IN ENDOVASCULAR EMBOLIZATION. THE GALAXY G3 MINI INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICROCOIL SYSTEM, EXAMINE FOR DAMAGE, AND REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS, WITHDRAW, AND EXAMINE THE DELIVERY CATHETER SYSTEM. IF THE MICROCOIL SYSTEM BECOMES IMMOBILE IN THE INFUSION MICROCATHETER, APPLY A GENTLE PUSH-PULL MOTION TO FREE IT. IF UNSUCCESSFUL, REMOVE BOTH MICROCATHETER AND MICROCOIL SYSTEM TOGETHER AS A UNIT AND REPLACE WITH NEW DEVICES. WITH THE AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING ANEURYSM/VESSEL CHARACTERISTICS, DEVICE INTERACTION, DEVICE SELECTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE / VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENCY COIL EMBOLIZATION PROCEDURE WITH THE TARGET LESION LOCATED ON THE INTERIOR CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC), A 2MM X 4CM GALAXY G3 MINI (GLM920040 / K10501) WAS THE SEVENTH COIL USED, BUT A STRONG RESISTANCE WAS FELT BETWEEN THE COIL AND THE CONCOMITANT MICROCATHETER (UNKNOWN / UNSPECIFIED BRAND) DURING ADVANCEMENT AND THE COIL PARTIALLY PROTRUDED FROM THE TIP OF THE MICROCATHETER. IT WAS REPORTED THAT THERE WAS A POSSIBILITY THAT THE TAIL OF THE PREVIOUSLY PLACED SIXTH COIL (COMPETITOR PRODUCT) REMAINED AT THE TIP OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL, BUT THE COIL BECAME ENTANGLED WITH THE IMPLANTED COIL MASS. THE COIL WAS ULTIMATELY REMOVED FROM THE PATIENT. THE TAIL OF AN UNSPECIFIED COIL EVENTUALLY HERNIATED FROM THE NECK OF THE ANEURYSM, REQUIRING STENT IMPLANTATION. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198566 GALAXY G3 MINI 2MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920040 K10501 10886704080305

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PHENOM¿ 17 MICROCATHETER (MEDTRONIC).