BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 MINI 2.5MM X 5.5CM

    MDR report key: 12260717 · Received August 2, 2021

    Report

    Report Number
    3008114965-2021-00368
    Event Type
    Injury
    Date Received
    August 2, 2021
    Date of Event
    July 21, 2021
    Report Date
    July 21, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080282
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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: A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF AN ARTERIOVENOUS FISTULA (AVF), A 2.5MM X 5.5CM GALAXY G3 MINI (GLM925055/K10172) COIL WAS PREMATURELY DETACHED INSIDE THE CONCOMITANT MICROCATHETER (SIZE/BRAND NOT SPECIFIED). THE PHYSICIAN REPOSITIONED THE MICROCATHETER PRIOR TO ADVANCING THE COIL INTO THE AVF AND BELIEVES THAT THIS MANEUVER MAY HAVE CAUSED THE COIL TO UNINTENDEDLY DETACH. IT WAS REPORTED THAT THERE WAS NO UNUSUAL UNSHEATHING OF COIL. AS THE PHYSICIAN PUSHED THE DELIVERY WIRE FORWARD, RESISTANCE WAS NOTICED AND REALIZED THE COIL HAD DETACHED. THE PHYSICIAN THEN ATTEMPTED TO USE A MICROWIRE TO ADVANCE THE PREMATURELY DETACHED COIL THROUGH THE MICROCATHETER, BUT HE WAS UNABLE TO PUSH THE COIL FORWARD WITH THAT TECHNIQUE. THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT AND THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THAT POINT. IT WAS REPORTED THAT THERE WAS NO NEGATIVE PATIENT OUTCOME AND NO SIGNIFICANT DELAY IN THE TREATMENT OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 28-JUL-2021 INDICATED THAT THE TARGET AVF WAS LOCATED AT THE DISTAL INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN FELT THAT THE AVF WAS ADEQUATELY TREATED. THIS COIL WAS LIKELY GOING TO BE THE LAST COIL OF THE CASE. THE SIZE/BRAND OF THE CONCOMITANT MICROCATHETER USED WAS NOT REPORTED. THE MICROCATHETER WILL NOT BE RETURNED FOR EVALUATION. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THERE WAS AN ADEQUATE FLUSH MAINTAINED THROUGH THE DEVICES. THE EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. A NON-STERILE GALAXY G3 MINI 2.5MM X 5.5CM WAS RECEIVED FOR ANALYSIS, THE DEVICE WAS INSPECTED, AND IT WAS FOUND THAT THE DPU IS KINKED AT 20 INCHES FROM PROXIMAL, NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED DURING THE VISUAL ANALYSIS. THE DEVICE WAS INSPECTED UNDER MICROSCOPE AND IT WAS NOTED THAT THE EMBOLIC COIL WAS MECHANICALLY DETACHED FROM THE DEVICE SINCE THE DISTAL OUTER SHEATH WAS FOUND NOT SOFTENED, INDICATING THAT THE RESISTANCE HEATING COIL HAD NOT BEEN HEATED AND THE HEATING PROCESS WAS NOT INITIATED. THE EMBOLIC COIL WAS NOT RETURNED FOR EVALUATION. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS IN WHICH THE DEVICE WAS RETURNED. DUE TO THE MECHANICALLY DETACHED CONDITION NOTED ON THE EMBOLIC COIL A SCANNING ELECTRON MICROSCOPE (SEM) TESTING WAS PERFORMED, THE RESULTS OF THE SCANNING ELECTRON MICROSCOPE (SEM) TEST ARE AS FOLLOWS: THERE IS EVIDENCE OF MECHANICAL DAMAGE AND STRESS MARKS ON CORE WIRE. THESE DAMAGES COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE OR EXCESSIVE FORCE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. NO OTHER ANOMALIES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE K10172 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. CERENOVUS CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. A FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS IN WHICH THE DEVICE WAS RETURNED. THE VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE DPU HAS A KINKED CONDITION. BASED ON THE FINDINGS DURING THE ANALYSIS, THE CUSTOMER COMPLAINT WAS CONFIRMED. A MICROSCOPIC TEST WAS PERFORMED, AND IT WAS NOTED THAT THE EMBOLIC COIL WAS MECHANICALLY DETACHED FROM THE DEVICE SINCE THE DISTAL OUTER SHEATH WAS FOUND NOT SOFTENED, INDICATING THAT THE RESISTANCE HEATING COIL HAD NOT BEEN HEATED AND THE HEATING PROCESS WAS NOT INITIATED; THIS CONDITION IS RELATED WITH THE CUSTOMER COMPLAINT REGARDING ¿COIL - PREMATURE DETACHMENT-IN MICROCATHETER¿, THE MECHANICALLY DETACHMENT OF THE COIL COULD BE THE RESULT OF THE RESISTANCE/FRICTION EXPERIENCE BY THE CUSTOMER AT THE PROCEDURE TIME, HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. BASED ON THE FINDINGS NOTED DURING THE ANALYSIS, THE CUSTOMER COMPLAINT WAS CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. UNUSUAL RESISTANCE/FRICTION DURING ADVANCEMENT AND PREMATURE DETACHMENT OF THE COIL ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH COIL EMBOLIZATION PROCEDURES. EXCESSIVE FORCE APPLIED TO A COIL THROUGH REPEATED COIL DEPLOYMENTS OR MANIPULATION CAN INCREASE THE POSSIBILITY OF PREMATURE DETACHMENT. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY THE LOCKING MECHANISM, OR CLEAR TAB IS UNLOCKED AND PULLED OUT FROM THE RESHEATHING TOOL APPROXIMATELY 1 IN (2-3 CM). ¿ IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM THROUGH THE INTRODUCER, OPEN THE RHV MAIN VALVE, AND PARTIALLY WITHDRAW THE DISTAL END OF THE INTRODUCER TO EXPOSE ITS TIP WITHIN THE RHV. TIGHTEN THE RHV MAIN VALVE, AND FLUSH THE Y-CONNECTOR OF THE RHV WITH STERILE SALINE AND VERIFY THAT FLUID EXITS THE SLIT IN THE CLEAR PORTION OF THE INTRODUCER. AFTER FLUSHING, REINSERT THE INTRODUCER INTO THE INFUSION CATHETER HUB AS DESCRIBED IN ¿MICROCOIL PLACEMENT¿ SECTION ABOVE. ¿ 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 AND EXAMINE FOR DAMAGE. REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS, WITHDRAW AND EXAMINE THE DELIVERY CATHETER SYSTEM. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE BASED ON THE INFORMATION AVAILABLE FOR REVIEW. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS INCLUDING AVF/VESSEL CHARACTERISTICS, ANATOMICAL CHALLENGES, DEVICE INTERACTION, DEVICE SELECTION, AND DEVICE MANIPULATION THAT MAY HAVE CONTRIBUTED RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 EVENTS WERE 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 WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF AN ARTERIOVENOUS FISTULA (AVF), A 2.5MM X 5.5CM GALAXY G3 MINI (GLM925055/K10172) COIL WAS PREMATURELY DETACHED INSIDE THE CONCOMITANT MICROCATHETER (SIZE/BRAND NOT SPECIFIED). THE PHYSICIAN REPOSITIONED THE MICROCATHETER PRIOR TO ADVANCING THE COIL INTO THE AVF AND BELIEVES THAT THIS MANEUVER MAY HAVE CAUSED THE COIL TO UNINTENDEDLY DETACH. IT WAS REPORTED THAT THERE WAS NO UNUSUAL UNSHEATHING OF COIL. AS THE PHYSICIAN PUSHED THE DELIVERY WIRE FORWARD, RESISTANCE WAS NOTICED AND REALIZED THE COIL HAD DETACHED. THE PHYSICIAN THEN ATTEMPTED TO USE A MICROWIRE TO ADVANCE THE PREMATURELY DETACHED COIL THROUGH THE MICROCATHETER, BUT HE WAS UNABLE TO PUSH THE COIL FORWARD WITH THAT TECHNIQUE. THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT AND THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THAT POINT. IT WAS REPORTED THAT THERE WAS NO NEGATIVE PATIENT OUTCOME AND NO SIGNIFICANT DELAY IN THE TREATMENT OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 28-JUL-2021 INDICATED THAT THE TARGET AVF WAS LOCATED AT THE DISTAL INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN FELT THAT THE AVF WAS ADEQUATELY TREATED. THIS COIL WAS LIKELY GOING TO BE THE LAST COIL OF THE CASE. THE SIZE/BRAND OF THE CONCOMITANT MICROCATHETER USED WAS NOT REPORTED. THE MICROCATHETER WILL NOT BE RETURNED FOR EVALUATION. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THERE WAS AN ADEQUATE FLUSH MAINTAINED THROUGH THE DEVICES. THE EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157193 GALAXY G3 MINI 2.5MM X 5.5CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM925055 K10172 10886704080282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNSPECIFIED MICROCATHETER| UNSPECIFIED MICROCATHETER