BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 6CM

    MDR report key: 8087277 · Received November 19, 2018

    Report

    Report Number
    3008114965-2018-00793
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    November 6, 2018
    Report Date
    November 6, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    10886704080312
    PMA / PMN Number
    K171862
    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 SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), AFTER THE INTRODUCTION OF THE MICROCATHETER, THREE COILS WERE IMPLANTED IN THE LESION. WHEN THE PHYSICIAN INSERTED THE 2 MM X 6 CM GALAXY G3 MINI COIL (GLM920060 / L12173), THERE WAS STRONG RESISTANCE BETWEEN THE COIL AND THE INTRODUCER AFTER IT WAS UNLOCKED TO START THE EMBOLIZATION PROCESS AND DURING ADVANCEMENT. THE COIL WAS REMOVED FROM THE Y-CONNECTOR AND IT BECAME UNRAVELED. THE 2 MM X 6 CM GALAXY G3 MINI COIL WAS REPLACED WITH ANOTHER 2 MM X 6 CM GALAXY G3 MINI COIL FROM LOT L12346. THIS REPLACEMENT COIL BECAME IMPEDED IN THE INTRODUCER AND WAS REPLACED WITH A SMALLER COIL (2MM X 4CM) AND THE PROCEDURE WAS CONTINUED AND WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY WITH THE PLACEMENT OF ANOTHER SMALLER COIL (1.5 X 3CM). THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE 2MM X 6CM GALAXY G3 MINI COIL WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED. INVESTIGATION SUMMARY: THE RETURNED DEVICE INFORMATION MATCHED THE COMPLAINT RECORD. THE EMBOLIC COIL WAS SEEN IN THE GREEN INTRODUCER SHEATH. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. THE EMBOLIC COIL WAS NOT SEEN TRAVELLING STRAIGHT WITHIN THE INTRODUCER AND WAS SEEN OSCILLATING AGAINST THE INNER WALLS OF THE INTRODUCER. THE COIL WAS SEEN TWISTED AROUND ITSELF AND KINKED INSIDE INTRODUCER SHEATH. NO STRETCHING DAMAGE WAS OBSERVED ON THE COIL. THERE WERE KINKS OBSERVED NEAR THE PROXIMAL END OF THE COIL. THE COIL COULD NOT BE ADVANCED DUE TO THE KINKED CONDITION IN WHICH IT WAS RETURNED. THE ARTICULATING JOINT WAS SEEN INTACT. THE DISTAL OUTER SHEATH COULD NOT BE OBSERVED DUE TO THE OPAQUENESS OF THE GREEN INTRODUCER. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L12173) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. INVESTIGATION CONCLUSION: THE COMPLAINT OF DETACHABLE COIL DELIVERY SYSTEM (DCS) RESISTANCE/FRICTION-DURING ADVANCEMENT WITH NO LOSS OF CEREBRAL TARGET POSITION IS CONFIRMED. THE POSITIONING OF THE COIL CAUSED THE COIL TO PRESS AGAINST THE INNER WALLS OF THE INTRODUCER AND BECOME IMPEDED. THE COIL WAS UNABLE TO BE ADVANCED. THE COMPLAINT OF COIL UNRAVELED/STRETCHED IS NOT CONFIRMED. THE COIL WAS SEEN KINKED; HOWEVER, NO STRETCHING WAS SEEN ON THE COIL. THE MICROCATHETER USED DURING THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS. THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE CAUSE OF THE RESISTANCE DURING THE PROCEDURE. THE INSTRUCTION FOR USE (IFU) PROVIDES INSTRUCTIONS FOR WHEN RESISTANCE IS FELT DURING DELIVERY. DEVICES UNDERGO 100% IN-PROCESS INSPECTION FOR THE EMBOLIC COIL ALONG THE ENTIRE LENGTH. IN ADDITION, ALL DEVICES UNDERGO FUNCTIONALITY VERIFICATION TO ENSURE THAT THE COIL IS ABLE TO ADVANCE FROM THE INTRODUCER SHEATH WITH NO ISSUES. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED ISSUES. WHILE THE REPORTED ISSUE THAT THE 2MM X 6CM GALAXY G3 MINI COIL BECAME UNRAVELED WHEN IT WAS REMOVED FROM THE Y-CONNECTOR WAS NOT CONFIRMED DURING THE EVALUATION AND ANALYSIS OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TWISTED AROUND ITSELF AND WAS KINKED INSIDE THE INTRODUCER SHEATH. THE WAVE-LIKE OSCILLATION OF THE COIL SEEN INSIDE THE INTRODUCER AND THE KINKED CONDITION PREVENTED IT FROM BEING ADVANCED. COIL KINKING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE IFU PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUE FROM OCCURRING. THE EXACT CAUSE OF THE KINKED EMBOLIC COIL COULD NOT BE CONCLUSIVELY DETERMINED, BUT THE KINKED COIL IS A FACTOR IN THE REPORTED ISSUE OF STRONG RESISTANCE BETWEEN THE COIL AND THE INTRODUCER AFTER IT WAS UNLOCKED TO START THE EMBOLIZATION PROCESS AND DURING ADVANCEMENT. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 12/20/2018. UPDATED SECTIONS: E.1: THE INITIAL REPORTER TITLE AND LAST NAME WAS ADDED. THE INITIAL REPORTER PHONE: (B)(6). [ADDITIONAL INFORMATION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), AFTER THE INTRODUCTION OF THE MICROCATHETER, THREE COILS WERE IMPLANTED IN THE LESION. WHEN THE PHYSICIAN INSERTED THE GALAXY G3 MINI 2MM X 6CM COIL (GLM920060 / L12173), THERE WAS STRONG RESISTANCE BETWEEN THE COIL AND THE INTRODUCER AFTER IT WAS UNLOCKED TO START THE EMBOLIZATION PROCESS AND DURING ADVANCEMENT. THE COIL WAS REMOVED FROM THE Y-CONNECTOR AND IT BECAME UNRAVELED. THE GALAXY G3 MINI 2MM X 6CM COIL WAS REPLACED WITH ANOTHER GALAXY G3 MINI 2MM X 6CM COIL FROM LOT L12346. THIS REPLACEMENT COIL BECAME IMPEDED IN THE INTRODUCER AND WAS REPLACED WITH A SMALLER COIL (2MM X 4CM) AND THE PROCEDURE WAS CONTINUED AND WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY WITH THE PLACEMENT OF ANOTHER SMALLER COIL (1.5 X 3CM). THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT HAS BEEN RETURNED AND IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. 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 · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO CORRECT THE MANUFACTURER INFORMATION. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. 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 · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO DOCUMENT THE RESULT OF THE ANALYSIS OF THE PRODUCTION RECORDS FOR LOT L12173. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT L12173 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED BY THE PRODUCT ANALYSIS LAB ON 12/13/2018. THE RETURN PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PRO CODE IS KRD/HCG. (B)(4). INITIAL REPORTER INFORMATION SUCH AS THE NAME, PHONE AND EMAIL ADDRESS ARE UNKNOWN. THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT L12173 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. 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 COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), AFTER THE INTRODUCTION OF THE MICROCATHETER, THREE COILS WERE IMPLANTED IN THE LESION. WHEN THE PHYSICIAN INSERTED THE GALAXY G3 MINI 2MM X 6CM COIL (GLM920060 / L12173), THERE WAS STRONG RESISTANCE AFTER IT WAS UNLOCKED TO START THE EMBOLIZATION PROCESS AND DURING ADVANCEMENT. THE COIL WAS REMOVED FROM THE Y-CONNECTOR AND IT BECAME UNRAVELED. THE GALAXY G3 MINI 2MM X 6CM COIL WAS REPLACED WITH ANOTHER GALAXY G3 MINI 2MM X 6CM COIL FROM LOT L12346. THIS REPLACEMENT COIL BECAME IMPEDED IN THE INTRODUCER AND WAS REPLACED WITH A SMALLER COIL (2MM X 4CM) AND THE PROCEDURE WAS CONTINUED AND WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY WITH THE PLACEMENT OF ANOTHER SMALLER COIL (1.5 X 3CM). THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924586 GALAXY G3 MINI 2MM X 6CM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD SEE H.10 L12173 10886704080312

    Patients

    Seq Age Sex Outcome Treatment
    1