BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1MM X 4CM

    MDR report key: 12202614 · Received July 21, 2021

    Report

    Report Number
    3008114965-2021-00326
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    May 16, 2021
    Report Date
    May 17, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080251
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE FINDINGS OF THE DEVICE INVESTIGATION. THE EMBOLIC COIL WAS NOTED AS BEING STRETCHED, MEETING REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. INITIAL REPORTER PHONE: (B)(6). 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 3008114965-2021-00327. AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ENPOWER CONTROL CABLE (ECB00018200, K10033) AND TWO COILS, A 1MM X 4CM GALAXY G3 MINI COIL (GLM910040, L15238) AND A 1MM X 4CM GALAXY G3 MINI COIL (GLM910040, L14682) WERE USED BUT THEY WERE NOT ABLE TO BE ENERGIZED DURING A PRE DETACHMENT ELECTRICAL CHECK. THEY WERE REPLACED WITH A COMPETITIVE DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ALL CONNECTIONS APPEAR TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE UNIT GALAXY G3 MINI 1MM X 4CM WAS RECEIVED AT CERENOVUS INSIDE OF A POUCH FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND THAT THE EMBOLIC COIL WAS PROTRUDED FROM INTRODUCER, NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED DURING THE VISUAL INSPECTION. A MICROSCOPIC INSPECTION WAS PERFORMED, AND IT WAS FOUND THAT THE EMBOLIC COIL IS STRETCHED AND PROTRUDED FROM INTRODUCER, THE PROTRUDED CONDITION IS NOT RELATED WITH THE CUSTOMER COMPLAINT. ALTHOUGH THE EMBOLIC COIL WAS FOUND STRETCHED AND PROTRUDED FROM INTRODUCER, THE FUNCTIONAL TEST WAS PERFORMED WITHOUT PROBLEM. THE RESISTANCE OF THE DEVICE GALAXY G3 MINI 1MM X 4CM WAS MEASURED WITH MULTIMETER. RESISTANCE MEASURED APPROXIMATELY 53.4 O, WHICH IS WITHIN THE SPECIFICATION RANGE. ALSO, THE DEVICE WAS CONNECTED TO DETACHMENT CONTROL BOX DCB2000500 (DCB) WITH THE RECEIVED ENPOWER CONTROL CABLE, AND THE POWER WAS TURNED ON. THE SYSTEM READY LIGHT WAS ILLUMINATING. THEN, THE DETACH BUTTON WAS PRESSED AND THE EMBOLIC COIL WAS DETACHED WITHOUT PROBLEM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE L15238 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. CERENOVUS CONDUCTED A VISUAL INSPECTION, MICROSCOPIC INSPECTION, AND A FUNCTIONAL TEST. DURING THE VISUAL ANALYSIS OF THE DEVICE, IT WAS NOTED THAT THE EMBOLIC COIL WAS PROTRUDED FROM INTRODUCER, NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED DURING THE VISUAL ANALYSIS. THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND IT WAS FOUND THAT THE EMBOLIC COIL IS STRETCHED AND PROTRUDED FROM INTRODUCER, THE PROTRUDED CONDITION NOTED ON THE EMBOLIC COIL IS NO RELATED WITH THE CUSTOMER COMPLAINT REGARDING A ¿DETACHABLE COIL DELIVERY SYSTEM (DCS) (THERMO-MECHANICAL DETACHMENT SYSTEM) - SYSTEM FAULT - PRE-DEPLOYMENT TEST¿. ALTHOUGH THE EMBOLIC COIL WAS FOUND STRETCHED AND PROTRUDED FROM INTRODUCER, THE FUNCTIONAL TEST WAS PERFORMED WITHOUT PROBLEM. SINCE THE FUNCTIONAL TEST WAS PERFORMED WITHOUT PROBLEM, THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATIONS: VERIFY THAT THE MICROCOIL DELIVERY SYSTEM IS FULLY CONNECTED, AND NO FAULTS ARE INDICATED ON THE DCB. IF A FAULT EXISTS, RESEAT ALL CONNECTIONS BETWEEN THE DPU, THE DCB, AND THE CONNECTING CABLE. IF A FAULT STILL PERSISTS, REPLACE THE CONNECTING CABLE. IF THIS DOES NOT CORRECT THE ERROR, REPLACE THE DCB. IF THE MICROCOIL DELIVERY SYSTEM STILL CONTINUES TO HAVE A FAULT, RETRIEVE THE MICROCOIL AS DESCRIBED IN THE FOLLOWING SECTION, RE SHEATHING THE MICROCOIL SYSTEM, AND REPLACE WITH A NEW MICROCOIL SYSTEM. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND DEVICE INTERACTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND DAMAGES ON THE RETURNED SYSTEM. AN EMBOLIC COIL BECOMES STRETCHED WHEN AN EXCESSIVE PULL FORCE IS APPLIED TO THE DEVICE. 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 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 THE FIELD, DURING A COIL EMBOLIZATION, AN ENPOWER CONTROL CABLE (ECB00018200, K10033) AND TWO COILS, A 1MM X 4CM GALAXY G3 MINI COIL (GLM910040, L15238) AND A 1MM X 4CM GALAXY G3 MINI COIL (GLM910040, L14682) WERE USED BUT THEY WERE NOT ABLE TO BE ENERGIZED DURING A PRE DETACHMENT ELECTRICAL CHECK. THEY WERE REPLACED WITH A COMPETITIVE DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ALL CONNECTIONS APPEAR TO FIT PROPERLY WITHOUT THE APPLICATION OF EXCESSIVE FORCE. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICES RECEIVED, THE EMBOLIC COILS WERE FOUND STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097901 GALAXY G3 MINI 1MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM910040 L15238 10886704080251

    Patients

    Seq Age Sex Outcome Treatment
    1