BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 6CM

    MDR report key: 12246284 · Received July 29, 2021

    Report

    Report Number
    3008114965-2021-00349
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 25, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080312
    PMA / PMN Number
    K171862
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 DAMAGED, MEETING REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG INITIAL REPORTER: THE CUSTOMER CONTACT INFORMATION, INCLUDING NAME, OCCUPATION, PHONE, FAX, AND E-MAIL ADDRESS, WAS NOT REPORTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE INTERNAL CAROTID ARTERY (ICA), THE PHYSICIAN TRIED TO RE-SHEATH A 2MM X 6CM GALAXY G3 COIL (GLM920060, K10703) AFTER DECIDING THAT THE COIL WAS AN UNPROPER CHOICE DURING THE PROCEDURE. HOWEVER, THE COIL FAILED TO RE-SHEATH AND THE DELIVERY WIRE WAS NOTED TO BEING SPLIT. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. NO ADDITIONAL INTERVENTION WAS REQUIRED. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY. A NON-STERILE UNIT GALAXY G3 MINI 2MM X 6CM WAS RECEIVED AT CERENOVIS INSIDE OF A POUCH FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS NOTED THAT THE CORE WIRE IS KINKED AND THE DPU IS PROTRUDED FROM INTRODUCER WITHOUT DAMAGES. NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED ON THE DEVICE DURING THE VISUAL ANALYSIS. THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND IT WAS FOUND THAT THE EMBOLIC COIL HAS A DAMAGE CONDITION. THE FUNCTIONAL TEST COULD NOT BE PERFORMED SINCE THE DPU WAS NOTED PROTRUDED FROM INTRODUCER. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE K10703 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. CERENOVUS CONDUCTED A VISUAL AND MICROSCOPIC INSPECTION. THE FUNCTIONAL TEST OF THE DEVICE COULD NOT BE PERFORMED DUE TO THE CONDITIONS IN WHICH THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL ANALYSIS OF THE GALAXY G3 MINI 2MM X 6CM, IT WAS NOTED THAT THE CORE WIRE IS KINKED, ALSO THE DPU WAS NOTED PROTRUDED FROM INTRODUCER WITHOUT DAMAGES. THE PROTRUDED CONDITION IS RELATED WITH THE CUSTOMER¿S COMPLAINTS REGARDING ¿COIL INTRODUCER - ZIPPING DIFFICULTY-REZIPPING¿ AND ¿COIL INTRODUCER - PREMATURE PEELING¿. BASED ON THE FINDINGS DURING THE ANALYSIS, THE CUSTOMER COMPLAINT WAS CONFIRMED. DURING THE MICROSCOPIC INSPECTION IT WAS OBSERVED THE EMBOLIC COIL IS DAMAGED. 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 CAUTIONS: NEVER ADVANCE, WITHDRAW, OR TORQUE THE DELIVERY TUBE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY. MANIPULATION OF THE DELIVERY TUBE AGAINST RESISTANCE CAN CAUSE DAMAGE AND/OR PREMATURE DETACHMENT OF THE COIL. IF UNUSUAL FRICTION IS NOTED WITHIN THE INFUSION CATHETER, REMOVE THE DETACHABLE COIL SYSTEM. REFER TO COIL RETRIEVAL. IF FRICTION IS NOTED WITH ANY SUBSEQUENT DETACHABLE COIL SYSTEM, CAREFULLY EXAMINE THE DETACHABLE COIL SYSTEM AND THE INFUSION CATHETER FOR POSSIBLE DAMAGE. REPLACE BOTH IF NECESSARY. REFER TO COIL RETRIEVAL. THE DETACHABLE COILS ARE DELICATE AND MUST BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE DURING THE PROCEDURE, INSPECT THE SYSTEM FOR BENDS OR KINKS. DO NOT USE A COIL SYSTEM SHOWING SIGNS OF DAMAGE. FAILURE TO OPEN THE SECOND RHV SUFFICIENTLY PRIOR TO SLOW AND CAREFUL REMOVAL OF THE DELIVERY TUBE FROM THE PATIENT COULD RESULT IN DAMAGE TO THE DISTAL PORTION OF THE DELIVERY TUBE. ASSIGNMENT OF ROOT CAUSE FOR THE EVENTS 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 FAILURES AND DAMAGES ON THE RETURNED SYSTEM. AS PART OF 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 TO THE INTERNAL CAROTID ARTERY (ICA), THE PHYSICIAN TRIED TO RE-SHEATH A 2MM X 6CM GALAXY G3 COIL (GLM920060, K10703) AFTER DECIDING THAT THE COIL WAS AN UNPROPER CHOICE DURING THE PROCEDURE. HOWEVER, THE COIL FAILED TO RE-SHEATH AND THE DELIVERY WIRE WAS NOTED TO BEING SPLIT. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. NO ADDITIONAL INTERVENTION WAS REQUIRED. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL HAS A DAMAGED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145948 GALAXY G3 MINI 2MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920060 K10703 10886704080312

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED MICROCATHETER