BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 6CM

    MDR report key: 9934771 · Received April 8, 2020

    Report

    Report Number
    3008114965-2020-00098
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    February 25, 2020
    Report Date
    February 25, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    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 · 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. PROCODE: KRD/HCG. INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE / REPORTED. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A 10MM INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC) ANEURYSM WITH SUBARACHNOID HEMORRHAGE (SAH), THE 10MM X 30CM AXIUM PRIME COIL (MEDTRONIC) FRAMING WAS USED AS THE FRAMING COIL FOLLOWED BY TWO 9MM X 25CM GLY120925 GALAXY G3 COILS, THREE 8MM X 30CM TARGET® SOFT DETACHABLE COILS (STRYKER), TWO 6MM X 20CM TARGET® SOFT DETACHABLE COILS (STRYKER), ONE 3MM X 8CM TARGET® SOFT DETACHABLE COIL (STRYKER), ONE 3MM X 8CM GLY120308 GALAXY G3 WERE USED BEFORE THE COMPLAINT COIL, A 2MM X 6CM GALAXY G3 MINI COIL (GLM920060 / L16329) WAS INSERTED INTO THE SHEATH INTRODUCER AND WAS NOT ABLE TO ADVANCE. THE PHYSICIAN REPLACED IT WITH A 2MM X 3CM AND THE REPLACEMENT COIL ADVANCED WITHOUT ANY ISSUE. ANOTHER 2MM X 6CM GALAXY G3 MINI COIL (GLM920060 / L14602) WAS USED BUT THE SAME ISSUE WAS ENCOUNTERED WHEN IT WAS INSERTED IN THE SHEATH INTRODUCER. IT WAS REPLACED WITH THE 2MM X 3CM TARGET® ULTRA COIL (STRYKER) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE 2MM X 6CM GALAXY G3 MINI COIL (GLM920060 / L16329) WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 2MM X 6CM GALAXY G3 MINI COIL WAS RECEIVED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE MARKER BAND WAS OBSERVED AT 40.9CM FROM THE HUB; THIS IS WITHIN SPECIFICATION. MICROSCOPIC INSPECTION WAS PERFORMED, AND THE EMBOLIC COIL WAS OBSERVED STRETCHED AND DAMAGED. NO OTHER ANOMALY WAS OBSERVED. THE STRETCHED AND DAMAGED CONDITION OF THE EMBOLIC COIL PRECLUDED FUNCTIONAL TESTING. THE COMPLAINT DOCUMENTED THAT THE COIL WAS IMPEDED IN THE INTRODUCER WAS CONFIRMED THROUGH THE MICROSCOPIC INSPECTION EVEN THOUGH FUNCTIONAL EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE STRETCHED AND DAMAGED CONDITION OF THE COIL IS LIKELY DUE TO FORCE APPLIED. THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L16329) 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. COIL STRETCHING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES PROPER HANDLING INSTRUCTION FOR THE DEVICE TO PREVENT SUCH ISSUE AS STRETCHING FROM OCCURRING. THE STRETCHED AND DAMAGED CONDITION OF THE COIL WAS NOT ORIGINALLY REPORTED IN THE COMPLAINT; HOWEVER, THE COIL WAS IMPEDED IN THE INTRODUCER. IT IS LIKELY THAT THE EMBOLIC COIL BECAME STRETCHED AND DAMAGED DURING THE ADVANCEMENT ATTEMPT WHERE FORCE MAY HAVE INADVERTENTLY BEEN APPLIED AND MAY HAVE CAUSED THE COIL TO BECOME STRETCHED AND DAMAGED AS WAS OBSERVED DURING THE MICROSCOPIC INSPECTION OF THE DEVICE. BASED ON THE REVIEW OF THE MANUFACTURING DOCUMENTATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. IN ADDITION, DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR THE CONDITION OF THE EMBOLIC COIL. THUS, IT IS NOT LIKELY THAT THE 2MM X 6CM GALAXY G3 MINI COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL IN THE STRETCHED AND DAMAGED CONDITION THAT WAS FOUND ON THE RETURNED DEVICE. 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 STRETCHED CONDITION OBSERVED ON THE RETURNED COIL WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2020-00098 AND 3008114965-2020-00099. 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 OF A 10MM INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC) ANEURYSM WITH SUBARACHNOID HEMORRHAGE (SAH), THE 10MM X 30CM AXIUM PRIME COIL (MEDTRONIC) FRAMING WAS USED AS THE FRAMING COIL FOLLOWED BY TWO 9MM X 25CM GLY120925 GALAXY G3 COILS, THREE 8MM X 30CM TARGET® SOFT DETACHABLE COILS (STRYKER), TWO 6MM X 20CM TARGET® SOFT DETACHABLE COILS (STRYKER), ONE 3MM X 8CM TARGET® SOFT DETACHABLE COIL (STRYKER), ONE 3MM X 8CM GLY120308 GALAXY G3 WERE USED BEFORE THE COMPLAINT COIL, A 2MM X 6CM GALAXY G3 MINI COIL (GLM920060 / L16329) WAS INSERTED INTO THE SHEATH INTRODUCER AND WAS NOT ABLE TO ADVANCE. THE PHYSICIAN REPLACED IT WITH A 2MM X 3CM AND THE REPLACEMENT COIL ADVANCED WITHOUT ANY ISSUE. ANOTHER 2MM X 6CM GALAXY G3 MINI COIL (GLM920060 / L14602) WAS USED BUT THE SAME ISSUE WAS ENCOUNTERED WHEN IT WAS INSERTED IN THE SHEATH INTRODUCER. IT WAS REPLACED WITH THE 2MM X 3CM TARGET® ULTRA COIL (STRYKER) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED IN STRETCHED AND DAMAGED CONDITION. BASED ON THE PRODUCT ANALYSIS 4/6/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404692 GALAXY G3 MINI 2MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920060 L16329 10886704080312

    Patients

    Seq Age Sex Outcome Treatment
    1