BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSFRAME18 8MM X 30CM

    MDR report key: 10708621 · Received October 20, 2020

    Report

    Report Number
    3008114965-2020-00441
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 2, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704078210
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE RETURNED COMPLAINT DEVICE ON 10/26/2020. THE RETURNED PRODUCT UNDERWENT EVALUATION AND ANALYSIS. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION WITH THE TARGET BEING A LEFT PULMONARY ARTERIOVENOUS FISTULA, A 5F SILICONE BALLOON CATHETER, A CARRY LEÓN HF MICROCATHETER (UTM), A CARRY LEÓN MICROCATHETER (UTM) WERE USED FOR FRAMING PURPOSES ON THE SAC PART OF THE PULMONARY ARTERIOVENOUS MALFORMATION (PAVM). THE 8MM X 30CM MICRUSFRAME 18 COIL (MFR180830 / K10011) WAS INSERTED INTO THE CARRY LEÓN MICROCATHETER. THE DELIVERY WIRE WAS ADVANCED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), BUT THERE WAS AN INTENSE RESISTANCE FELT WHEN HALF OF THE SYSTEM ADVANCED. THE DELIVERY WIRE WAS RETRACTED BUT THE COIL WAS NOT ABLE TO BE INSERTED INTO THE INTRODUCER. THE INTRODUCER SHEATH WAS REMOVED FROM THE HUB OF THE MICROCATHETER AND THE COIL PART WAS OBSERVED ALREADY DETACHED FROM THE DELIVERY WIRE. THE COMPLAINT COIL WAS REMOVED BECAUSE THE EXPOSED PART OF THE HUB WAS CAUGHT. IT WAS REPLACED WITH ANOTHER COIL AND WAS INSERTED INTO THE MICROCATHETER AND DELIVERED WITHOUT ANY PROBLEM. THE PROCEDURE RESUMED AND THE FOLLOWING COILS WERE USED TO EMBOLIZED THE SAC: 7MM X 21CM GALAXY G3 (GLY120721), 8MM X 24CM GALAXY G3 (GLY120824). THE MAIN ARTERIAL TRUNK IN FRONT OF THE SAC WERE IMPLANTED WITH THE FOLLOWING COILS FOR PARTIAL PRESSURE OF ARTERIAL BLOOD (PAO) SUPPORT: TWO 4MM X 12CM GALAXY G3 (GLY120412), TWO 3MM X 8CM GALAXY G3 (GLY120308), AND A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505). THE PROCEDURE WAS COMPLETED WITH THE FOLLOWING COILS IMPLANTED IN SUCCESSION TO ACHIEVE PAO AND TO COMPLETE THE PROCEDURE: 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208), 3MM X 6CM GALAXY G3 XSFT (GLX120306), 3MM X 4CM GALAXY G3 XSFT (GLX120304), 2.5MM X 5CM GALAXY G3 XSFT (GLX122505), 3MM X 4CM GALAXY G3 XSFT (GLX120304), 3MM X 8CM GALAXY G3 (GLY120308), AND 4MM X 12CM GALAXY G3 (GLY120412). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THE REPORTED EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT PROCEDURE DELAY. THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED EVENT. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 8MM X 30CM MICRUSFRAME 18 COIL WAS RETURNED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE COIL INTRODUCER WAS OBSERVED SEPARATED FROM THE REST OF THE DEVICE. NO OTHER DAMAGE WAS OBSERVED DURING THE VISUAL INSPECTION. MICROSCOPIC INSPECTION WAS PERFORMED. THE EMBOLIC COIL WAS OBSERVED TO BE SLIGHTLY KINKED AND MECHANICALLY DETACHED FROM THE DEVICE. FUNCTIONAL EVALUATION WAS NOT CONDUCTED DUE TO THE COIL ALREADY DETACHED FROM THE DEVICE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10011) 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. THE COMPLAINT DOCUMENTED THAT THE 8MM X 30CM MICRUSFRAME 18 COIL WAS INSERTED INTO THE CARRY LEÓN MICROCATHETER. THE DELIVERY WIRE WAS ADVANCED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), BUT THERE WAS AN INTENSE RESISTANCE FELT WHEN HALF OF THE SYSTEM ADVANCED. THE DELIVERY WIRE WAS RETRACTED BUT THE COIL WAS NOT ABLE TO BE INSERTED INTO THE INTRODUCER. THE INTRODUCER SHEATH WAS REMOVED FROM THE HUB OF THE MICROCATHETER AND THE COIL PART WAS OBSERVED ALREADY DETACHED FROM THE DELIVERY WIRE. THE ISSUE RELATED TO THE INTRODUCER SHEATH WAS CONFIRMED BASED ON THE VISUAL INSPECTION PERFORMED; THE INTRODUCER WAS OBSERVED SEPARATED FROM THE REST OF THE DEVICE. THE ISSUE RELATED TO THE RESISTANCE THAT WAS FELT COULD NOT BE CONFIRMED THROUGH FUNCTIONAL EVALUATION AS THE INTRODUCER WAS SEPARATED FROM THE REST OF THE DEVICE, THE EMBOLIC COIL WAS SLIGHTLY KINKED AND MECHANICALLY DETACHED. CONFIRMATION IS BASED ON THE VISUAL AND MICROSCOPIC INSPECTIONS THAT WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED ISSUE THAT THE COIL WAS DETACHED FROM THE DELIVERY WIRE WAS CONFIRMED; THE RETURNED DEVICE UNDERWENT MICROSCOPIC INSPECTION AND THE EMBOLIC COIL WAS SLIGHTLY KINKED AND DETACHED FROM THE DEVICE. COIL KINKING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTION FOR USE PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT ISSUES SUCH AS KINK FROM OCCURRING. THE OBSERVED SLIGHTLY KINKED CONDITION WAS NOT ORIGINALLY REPORTED WITH THE COMPLAINT. THE EXACT CAUSE OF THE OBSERVED KINKED CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY HAVE BEEN THE RESULT OF INADVERTENT FORCE THAT MAY HAVE BEEN APPLIED DURING THE PROCEDURE HANDLING. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR THE CONDITION OF THE EMBOLIC COIL. THUS, IT IS NOT LIKELY THAT THE 8MM X 30CM MICRUSFRAME 18 COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL IN A SLIGHTLY KINKED CONDITION AND MECHANICALLY ALREADY DETACHED AS OBSERVED 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 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 · 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 IS KRD/HCG. INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE / REPORTED. 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 REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10011) 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. 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 WITH THE TARGET BEING A LEFT PULMONARY ARTERIOVENOUS FISTULA, A 5F SILICONE BALLOON CATHETER, A CARRY LEÓN HF MICROCATHETER (UTM), A CARRY LEÓN MICROCATHETER (UTM) WERE USED FOR FRAMING PURPOSES ON THE SAC PART OF THE PULMONARY ARTERIOVENOUS MALFORMATION (PAVM). THE 8MM X 30CM MICRUSFRAME 18 COIL (MFR180830 / K10011) WAS INSERTED INTO THE CARRY LEÓN MICROCATHETER. THE DELIVERY WIRE WAS ADVANCED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), BUT THERE WAS AN INTENSE RESISTANCE FELT WHEN HALF OF THE SYSTEM ADVANCED. THE DELIVERY WIRE WAS RETRACTED, BUT THE COIL WAS NOT ABLE TO BE INSERTED INTO THE INTRODUCER. THE INTRODUCER SHEATH WAS REMOVED FROM THE HUB OF THE MICROCATHETER AND THE COIL PART WAS OBSERVED ALREADY DETACHED FROM THE DELIVERY WIRE. THE COMPLAINT COIL WAS REMOVED BECAUSE THE EXPOSED PART OF THE HUB WAS CAUGHT. IT WAS REPLACED WITH ANOTHER COIL, WAS INSERTED INTO THE MICROCATHETER, AND DELIVERED WITHOUT ANY PROBLEM. THE PROCEDURE RESUMED AND THE FOLLOWING COILS WERE USED TO EMBOLIZED THE SAC: 7MM X 21CM GALAXY G3 (GLY120721), 8MM X 24CM GALAXY G3 (GLY120824). THE MAIN ARTERIAL TRUNK IN FRONT OF THE SAC WERE IMPLANTED WITH THE FOLLOWING COILS FOR PARTIAL PRESSURE OF ARTERIAL BLOOD (PAO) SUPPORT: TWO 4MM X 12CM GALAXY G3 (GLY120412), TWO 3MM X 8CM GALAXY G3 (GLY120308), AND A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505). THE PROCEDURE WAS COMPLETED WITH THE FOLLOWING COILS IMPLANTED IN SUCCESSION TO ACHIEVE PAO AND TO COMPLETE THE PROCEDURE: 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208), 3MM X 6CM GALAXY G3 XSFT (GLX120306), 3MM X 4CM GALAXY G3 XSFT (GLX120304), 2.5MM X 5CM GALAXY G3 XSFT (GLX122505), 3MM X 4CM GALAXY G3 XSFT (GLX120304), 3MM X 8CM GALAXY G3 (GLY120308), AND 4MM X 12CM GALAXY G3 (GLY120412). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THE REPORTED EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT PROCEDURE DELAY. THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172513 MICRUSFRAME18 8MM X 30CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL MFR180830 K10011 10886704078210

    Patients

    Seq Age Sex Outcome Treatment
    1 5F SILICONE BALLOON CATHETER (UNKNOWN BRAND)| CARRY LEÓN HF MICROCATHETER (UTM)| CARRY LEÓN MICROCATHETER (UTM)| ENPOWER CONTROL CABLE| GALAXY G3 3MM X 8CM| GALAXY G3 3MM X 8CM| GALAXY G3 4MM X 12CM| GALAXY G3 4MM X 12CM| GALAXY G3 7MM X 21CM| GALAXY G3 8MM X 24CM| GALAXY G3 XSFT 2.5MM X 5CM| GALAXY G3 XSFT 2.5MM X 5CM| GALAXY G3 XSFT 2.5MM X 5CM| GALAXY G3 XSFT 2.5MM X 5CM| GALAXY G3 XSFT 2.5MM X 5CM| GALAXY G3 XSFT 3MM X 4CM| GALAXY G3 XSFT HEL 2MM X 8CM| GALAXY G3 XSFT HEL 2MM X 8CM| GALAXY G3 XSFT HEL 2MM X 8CM