BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 XSFT 2.5MM X 5CM

    MDR report key: 10303441 · Received July 21, 2020

    Report

    Report Number
    3008114965-2020-00262
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 2, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077626
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 7/28/2020. [ADDITIONAL INFORMATION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE A SUBARACHNOID HEMORRHAGE (SAH) COIL EMBOLIZATION PROCEDURE WITH THE LOCATION OF THE SAH AT THE INTERNAL CAROTID ARTERY (ICA), THE 2.5MM X 5CM GALAXY G3 XSFT COIL (GLX122505 / L13187) WAS USED PER THE INSTRUCTIONS FOR USE (IFU), BUT THERE WAS RESISTANCE FELT BETWEEN THE COIL AND THE CONCOMITANT SL-10® MICROCATHETER (STRYKER). THE RESISTANCE OCCURRED WHEN THE COIL WAS ADVANCED THROUGH THE MICROCATHETER. IT WAS REPORTED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN RETRACTED THE DELIVERY WIRE TO CONFIRM THE SITUATION. THE COMPLAINT COIL APPEARED TO HAVE UNRAVELED AND WAS NO LONGER USABLE. THE MICROCATHETER WAS FLUSHED AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL. THE REPLACEMENT COIL WAS USED WITHOUT ANY ISSUE. THERE WAS NO RESTRICTION / REDUCTION IN BLOOD FLOW AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROCEDURAL DELAY OR PROLONGATION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. E.1: THE INITIAL REPORTER PHONE: (B)(6). THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). PROCODE IS KRD/HCG. THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE A SUBARACHNOID HEMORRHAGE (SAH) COIL EMBOLIZATION PROCEDURE, THE 2.5MM X 5CM GALAXY G3 XSFT COIL (GLX122505 / L13187) WAS USED PER THE INSTRUCTIONS FOR USE (IFU), BUT THERE WAS RESISTANCE FELT BETWEEN THE COIL AND THE CONCOMITANT SL-10® MICROCATHETER (STRYKER). THE RESISTANCE OCCURRED WHEN THE COIL WAS ADVANCED THROUGH THE MICROCATHETER. THE PHYSICIAN RETRACTED THE DELIVERY WIRE TO CONFIRM THE SITUATION. THE COMPLAINT COIL APPEARED TO HAVE UNRAVELED AND WAS NO LONGER USABLE. THE MICROCATHETER WAS FLUSHED AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL. THE REPLACEMENT COIL WAS USED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L13187) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AND CONCOMITANT MICROCATHETER AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT CANNOT BE CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND / OR DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE A SUBARACHNOID HEMORRHAGE (SAH) COIL EMBOLIZATION PROCEDURE, THE 2.5MM X 5CM GALAXY G3 XSFT COIL (GLX122505 / L13187) WAS USED PER THE INSTRUCTIONS FOR USE (IFU), BUT THERE WAS RESISTANCE FELT BETWEEN THE COIL AND THE CONCOMITANT SL-10® MICROCATHETER (STRYKER). THE RESISTANCE OCCURRED WHEN THE COIL WAS ADVANCED THROUGH THE MICROCATHETER. THE PHYSICIAN RETRACTED THE DELIVERY WIRE TO CONFIRM THE SITUATION. THE COMPLAINT COIL APPEARED TO HAVE UNRAVELED AND WAS NO LONGER USABLE. THE MICROCATHETER WAS FLUSHED AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL. THE REPLACEMENT COIL WAS USED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767068 GALAXY G3 XSFT 2.5MM X 5CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLX122505 L13187 10886704077626

    Patients

    Seq Age Sex Outcome Treatment
    1 SL-10® MICROCATHETER (STRYKER).