BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 4CM

    MDR report key: 11494499 · Received March 16, 2021

    Report

    Report Number
    3008114965-2021-00119
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    January 15, 2021
    Report Date
    January 17, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080305
    PMA / PMN Number
    K171862
    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 AS BEING 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. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE RE-SHEATING OF A 2MM X 4CM GALAXY G3 MINI COIL (GLM920040, K10524) FAILED WHEN THE PHYSICIAN TRIED RE-CAPTURE THE COIL. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE UNIT GALAXY G3 MINI 2MM X 4CM WAS RECEIVED INSIDE OF A POUCH. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND THAT THE CORE WIRE IS KINKED AND PROTRUDED FROM THE INTRODUCER. NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED DURING THE VISUAL INSPECTION. ALSO, THE MARKER BAND WAS FOUND AT 39 CM FROM THE HUB, WHICH IS WITHIN SPECIFICATION. THE EMBOLIC COIL WAS INSPECTED UNDER A MICROSCOPE AND IT WAS FOUND WITH A DAMAGED CONDITION INSIDE THE INTRODUCER. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE K10524 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE KINKED AND PROTRUDED CONDITIONS NOTED ON THE CORE WIRE DURING THE VISUAL ANALYSIS ARE RELATED TO THE CUSTOMER¿S COMPLAINT REGARDING A ZIPPING DIFFICULTY-REZIPPING. IT MAY HAVE BEEN RELATED TO AN EXCESSIVE FORCE AND/OR HANDLING APPLIED TO THE DEVICE DURING THE PROCEDURE. HOWEVER, THESE CANNOT CONCLUSIVELY DETERMINE. ALSO, THE DAMAGE CONDITION OBSERVED ON THE EMBOLIC COIL DURING THE MICROSCOPIC ANALYSIS APPEARS TO MIGHT HAVE BEEN CAUSED BY EXCESSIVE FORCE AND/OR HANDLING APPLIED TO THE DEVICE DURING THE PROCEDURE, HOWEVER, THESE CANNOT CONCLUSIVELY DETERMINE. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING CAUTION: DO NOT PULL THE DPU WIRE BACK TOO FAR SINCE IT MAY CAUSE A SOFTER SECTION OF THE DPU WIRE TO BECOME EXPOSED. AN ARM¿S LENGTH PULL SHOULD RE-SHEATH THE COIL, THIS COULD BE RELATED TO THE PROTRUDED CONDITION NOTED ON THE CORE WIRE. BASED ON THE FINDINGS DURING THE INVESTIGATION, THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IF INFORMATION IS PROVIDED AT A LATER DATE, THE FILE WILL BE REOPENED AND PROCESSED ACCORDINGLY. 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, THE RE-SHEATING OF A 2MM X 4CM GALAXY G3 MINI COIL (GLM920040, K10524) FAILED WHEN THE PHYSICIAN TRIED RE-CAPTURE THE COIL. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS ON THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390332 GALAXY G3 MINI 2MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920040 K10524 10886704080305

    Patients

    Seq Age Sex Outcome Treatment
    1