BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 5MM X 15CM

    MDR report key: 11170550 · Received January 14, 2021

    Report

    Report Number
    3008114965-2021-00028
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    December 21, 2020
    Report Date
    December 21, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077510
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UPDATED SECTIONS ON THIS MEDWATCH REPORT: D9, G3, G6, H2, H3, H6 AND H10. 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 TVER ENDOLEAK PROCEDURE, COILING EMBOLIZATION WAS PERFORMED AT THE SMALL BAY SIDE OF THE STENT. THIS PROCEDURE WAS ADDITIONAL BECAUSE THERE WAS A PREVIOUS STENT THERE. A 5MM X 15CM GALAXY G3 COIL (GLY120515, K10389) WAS USED AS THE TWELFTH COIL BUT IT BECAME KINKED. A CONCOMITANT MICROCATHETER (BREAKTHROUGH, BOSTON SCIENTIFIC) GOT KINKED AS WELL. IT MIGHT HAVE OCCURRED BECAUSE THE PREVIOUS COIL WAS ALREADY ¿CLOGGED¿ AND THE CATHETER WAS FORCIBLY INSERTED AND EMBOLIZED. THE PHYSICIAN ATTEMPTED TO RE-SHEATH BUT IT WAS NOT ABLE TO BE RE-SHEATHED AS IT WAS KINKED. AFTER THAT, THE MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZED COIL. IT WAS EMBOLIZED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE PHYSICIAN DID NOT FEEL THE PROLONGATION OF THE PROCEDURE WAS CLINICALLY SIGNIFICANT. THE LESION WAS THE AORTIC ARCH SMALL BAY SIDE BUT NO FURTHER INFORMATION WAS PROVIDED. A NON-STERILE UNIT GALAXY G3 5MM X 15CM WAS RECEIVED INSIDE OF A POUCH. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND THAT THE DPU IS KINKED AT 39.5 CM. ALSO, THE CORE WIRE WAS NOTED TO HAVE SEVERAL KINKS AND PROTRUDED FROM INTRODUCER. NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED DURING THE VISUAL INSPECTION. ALSO, THE MARKER BAND WAS FOUND AT 50 CM FROM HUB, AND IT WAS FOUND WITHIN SPECIFICATION. THE DEVICE WAS INSPECTED UNDER MICROSCOPE AND IT WAS NOTED THAT EMBOLIC COIL IS IN GOOD NORMAL CONDITIONS INSIDE THE INTRODUCER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE K10389 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE COMPLAINT REPORTED BY THE CUSTOMER ¿COIL - KINKED/BENT-IN PATIENT¿ WAS NOT CONFIRMED. DURING THE ANALYSIS THE EMBOLIC COIL WAS FOUND IN GOOD NORMAL CONDITIONS INSIDE THE INTRODUCER, HOWEVER, THE DPU AND CORE WIRE WAS FOUND KINKS AND THESE CONDITIONS COULD BE RELATED WITH THE CUSTOMER¿S REPORT OF A KINKED CONDITION. HOWEVER, THESE CONDITIONS WERE NOT NOTED ON THE EMBOLIC COIL. THE KINKED CONDITION NOTED ON THE DEVICE COULD BE RELATED WITH COGGLED CONDITION MENTIONED ON THE EVENT DESCRIPTION AND/OR MAY HAVE BEEN CAUSED BY EXCESSIVE FORCE AND/OR HANDLING APPLIED TO THE DEVICE, THIS CANNOT CONCLUSIVELY DETERMINE. NEITHER THE ANALYSIS NOR THE MRE SUGGESTS THAT THE FAILURE REPORTED BY THE CUSTOMER COULD NOT BE RELATED TO THE MANUFACTURING PROCESS. KINKED COIL IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE IFU CONTAINS INSTRUCTIONS AND CAUTIONS REGARDING PROPER PLACEMENT OF THE DEVICE, INCLUDING INTRODUCTION AND POSITIONING OF THE MICROCOIL. 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. IT WAS NOTED IN THE EVENT DESCRIPTION THAT THE CATHETER WAS FORCIBLY INSERTED AND EMBOLIZED WHICH MIGHT HAVE CAUSED THE KINK. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. INITIAL REPORTER PHONE ¿ (B)(6). 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

    AS REPORTED BY THE FIELD, DURING A TVER ENDOLEAK PROCEDURE, COILING EMBOLIZATION WAS PERFORMED AT THE SMALL BAY SIDE OF THE STENT. THIS PROCEDURE WAS ADDITIONAL BECAUSE THERE WAS A PREVIOUS STENT THERE. A 5MM X 15CM GALAXY G3 COIL (GLY120515, K10389) WAS USED AS THE TWELFTH COIL BUT IT BECAME KINKED. A CONCOMITANT MICROCATHETER (BREAKTHROUGH, BOSTON SCIENTIFIC) GOT KINKED AS WELL. IT MIGHT HAVE OCCURRED BECAUSE THE PREVIOUS COIL WAS ALREADY ¿CLOGGED¿ AND THE CATHETER WAS FORCIBLY INSERTED AND EMBOLIZED. THE PHYSICIAN ATTEMPTED TO RE-SHEATH BUT IT WAS NOT ABLE TO BE RE-SHEATHED AS IT WAS KINKED. AFTER THAT, THE MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZED COIL. IT WAS EMBOLIZED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE PHYSICIAN DID NOT FEEL THE PROLONGATION OF THE PROCEDURE WAS CLINICALLY SIGNIFICANT. THE LESION WAS THE AORTIC ARCH SMALL BAY SIZE BUT NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69556 GALAXY G3 5MM X 15CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLY120515 K10389 10886704077510

    Patients

    Seq Age Sex Outcome Treatment
    1 BREAKTHROUGH, BOSTON SCIENTIFIC MICROCATHETER