BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 1MM X 4CM

    MDR report key: 12810669 · Received November 15, 2021

    Report

    Report Number
    3008114965-2021-00570
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 26, 2021
    Report Date
    November 15, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. (B)(6). 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 OF A 5MM ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACA), A PRIMEFRAME COIL WAS USED AS FRAMING COIL AND FILLING STARTED WITH AN IED COIL. THE COMPLAINT, A GALAXY G3 MINI 1MM X 4CM ( GLM910040, K10701) WAS INSERTED. IT WAS WOUND SEVERAL TIMES, BUT THE COIL PART BECAME UNRAVELED. IT DID NOT SEEM TO BE ENTANGLED WITH THE PREVIOUS COILS. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. A CONTINUOUS FLUSH WAS DONE. A SL10 MICROCATHETER (MC) WAS USED AS A CONCOMITANT DEVICE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL HAD BEEN INSPECTED PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. THERE WAS NO PROLONGATION DURING THE PROCEDURE DUE TO THE EVENT. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE K10701 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT OF ¿COIL ¿ UNRAVELED¿ COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING RECORD EVALUATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT DEVICES; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION/INTERACTION, ANEURYSM SIZE AND VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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 · 0

    AS REPORTED BY THE FIELD, DURING COIL EMBOLIZATION OF A 5MM ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACA), A PRIMEFRAME COIL WAS USED AS FRAMING COIL AND FILLING STARTED WITH AN IED COIL. THE COMPLAINT, A GALAXY G3 MINI 1MM X 4CM ( GLM910040, K10701) WAS INSERTED. IT WAS WOUND SEVERAL TIMES, BUT THE COIL PART BECAME UNRAVELED. IT DID NOT SEEM TO BE ENTANGLED WITH THE PREVIOUS COILS. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. A CONTINUOUS FLUSH WAS DONE. A SL10 MICROCATHETER (MC) WAS USED AS A CONCOMITANT DEVICE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL HAD BEEN INSPECTED PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. THERE WAS NO PROLONGATION DURING THE PROCEDURE DUE TO THE EVENT. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713511 GALAXY G3 MINI 1MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM910040 K10701 10886704080251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PRIME FRAME COIL| SL10 MICROCATHETER