GALAXY G3 XSFT 4MM X 8CM
Report
- Report Number
- 3008114965-2022-00259
- Event Type
- Malfunction
- Date Received
- April 14, 2022
- Date of Event
- March 29, 2022
- Report Date
- June 9, 2022
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- KRD
- UDI-DI
- 10886704077732
- PMA / PMN Number
- K150319
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER¿S REF. NO: PC- (B)(4). INFORMATION REGARDING PATIENT DATE OF BIRTH, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. PROCODE IS KRD/HCG. THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT REPORTED / AVAILABLE. 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 (K10708) 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 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.
MANUFACTURER¿S REF. NO: PC-(B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED THE PRODUCT ANALYSIS LAB ON 31-MAY-2022. THE RETURN PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.6. H.2, H.3, H.6, AND H.10. 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.
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 AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA), BETWEEN THE COMMUNICATING SEGMENT AND THE CAROTID ARTERY, THE DEVICE WAS PURGED AND INSERTED INTO THE MICROCATHETER HUB. THE 4MM X 8CM GALAXY G3 XSFT COIL (GLX120408 / K10708) WAS ADVANCED, BUT THE DEVICE WAS NOT OBSERVED / SEEN IN FLUOROSCOPY. AS A RESULT, THE MICROCATHETER WAS COMPLETELY WITHDRAWN AND THE GUIDEWIRE WITHOUT THE CORRESPONDING COIL WAS OBSERVED. SUBSEQUENTLY, IT WAS VERIFIED UNDER FLUOROSCOPY THAT THE COIL WAS RELEASED IN THE MICROCATHETER WHILE IT WAS BEING ADVANCED. THE MICROCATHETER WAS CHANGED AND OTHER COILS WERE USED. ANEURYSM CLIPPING WAS REQUIRED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 19-APR-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PHYSICIAN READ THE INSTRUCTIONS FOR USE (IFU); THE IFU DOES CLEARLY DESCRIBE HOW TO USE THE MEDICAL DEVICE AND THE PHYSICIAN HAVE BEEN TRAINED IN ITS USE. THE ADDITIONAL INFORMATION ALSO INCLUDED THE OBSERVATIONS FROM THE PHYSICIAN: ¿FROM THE BEGINNING THE DOCTOR WAS GIVEN A PRESENTATION FOR THE HANDLING OF THE COIL AND WE TOOK THE USE OF THE VIDEOS, AND IN MANY CASES WHEN THE COIL IS SHEATHED IT DOES NOT PRESENT A PROBLEM. THE SAME STEPS ARE ALWAYS PERFORMED IT APPEARS THAT THE EVENT OF HYPOTUBE BREAKS AND WE HAVE SUPPORTED THE PHYSICIAN TO REVIEW THE PROCESS DURING THE PROCEDURE. AT THE VISIT OF THE BRAND SPECIALIST THE DOCTOR COMMENTED IN DETAIL ABOUT THIS FAILURE AND WENT THROUGH THE STEPS, WHERE IT WAS CLARIFIED THAT THE DOCTOR WAS DOING THE PROCESS AS IS FOR THE RECOVERY OF THE COIL, AND IT WAS NOT POSSIBLE TO EXPLAIN CONCLUSIVELY WHAT WAS GOING ON.¿ ON 20-APR-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE CHANGE IN TECHNIQUE (ANEURYSM CLIPPING) WAS DUE TO THE PREFERENCE OF THE PHYSICIAN. THE PHYSICIAN COULD NOT DO THE FULL EMBOLIZATION. THE VESSEL WAS NOT TORTUOUS. THE INFORMATION INDICATED THAT THERE WAS RESISTANCE ENCOUNTERED DURING THE ADVANCEMENT OF THE COIL DELIVERY SYSTEM THROUGH THE CONCOMITANT MICROCATHETER, A 150CM X 50CM PROWLER 14 MICROCATHETER (606151FX / 30289569); THE RESISTANCE WAS FIRST FELT INSIDE THE MICROCATHETER AT THE MID-SECTION. THE DEVICE WAS STUCK. THE EMBOLIC COIL BECAME PREMATURELY DETACHED AT THE DETACHMENT ZONE ON THE DEVICE POSITIONING UNIT; IT DID NOT BECOME SEPARATED INTO TWO OR MORE PIECES. THE INFORMATION INDICATED THAT THE CONCOMITANT MICROCATHETER WAS SUCCESSFULLY USED WITH OTHER DEVICES PRIOR TO THE ENCOUNTERED RESISTANCE. THE MICROCATHETER WAS USED WITH A 4MM X 8CM DELTAXSFT (DLX100408 / 30607239), AND A 3MM X 10CM TARGET 360 ULTRA COIL (STRYKER). THE CONCOMITANT MICROCATHETER WAS NOT DAMAGED DURING THE MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE COIL ADVANCEMENT. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. ANOTHER 150CM X 50CM PROWLER 14 MICROCATHETER (606151FX / 30289569) WAS USED TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 4MM X 8CM GALAXY G3 XSFT COIL AND A NON-STERILE PROWLER 14 MICROCATHETER WERE RECEIVED. VISUAL INSPECTION WAS PERFORMED ON THE 4MM X 8CM GALAXY G3 XSFT COIL. THE DEVICE POSITIONING UNIT (DPU) WAS OBSERVED KINKED AT 97CM AND 112 CM FROM THE PROXIMAL END. IT WAS ALSO NOTED THAT THE EMBOLIC COIL IS NOT ATTACHED TO THE REST OF THE DEVICE. NO OTHER DAMAGES WERE OBSERVED DURING THE VISUAL INSPECTION. THE PROWLER 14 MICROCATHETER WAS ANALYZED TO DETERMINE IF THERE WERE FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT. DURING THE INSPECTION OF THE PROWLER 14 MICROCATHETER, A KINKED WAS NOTED AT 19CM FROM THE PROXIMAL END. THERE WERE COMPRESSED AREAS OBSERVED AT 106 CM, 113 CM, AND 118 CM FROM THE PROXIMAL END. A GUIDEWIRE WAS INTRODUCED THROUGH THE MICROCATHETER, AND IT WAS ADVANCED, HOWEVER, IT GOT STUCK AT 17CM FROM THE PROXIMAL END, A CATHETER DISSECTION WAS PERFORMED IN THIS AREA. THE PROXIMAL PORTION OF THE EMBOLIC COIL WAS FOUND KNOTTED AND STUCK INSIDE THE MICROCATHETER. ADDITIONAL DISSECTIONS WERE PERFORMED ALONG THE MICROCATHETER, AND THE EMBOLIC COIL COMPONENT WAS OBSERVED TO BE SEVERELY STRETCHED. IT WAS ALSO NOTED THAT ANOTHER PORTION OF THE EMBOLIC COIL WAS KNOTTED AT THE DISTAL END; THE EMBOLIC COIL COMPONENT WAS STUCK INSIDE THE PROWLER 14 MICROCATHETER AT 97CM FROM THE PROXIMAL END. MICROSCOPIC INSPECTION WAS PERFORMED. UNDER MAGNIFICATION, IT WAS NOTED THAT THE SOLDER JOINT OF THE EMBOLIC COIL WAS STILL ATTACHED TO THE DEVICE POSITIONING UNIT (DPU) FRAGMENT. THE SOCKET RING OF THE SOLDER JOINT HAD A DAMAGED (STRETCHED) CONDITION. THE EMBOLIC COIL COMPONENT WAS OBSERVED MECHANICALLY DETACHED FROM THE SOLDER JOINT. THE INNER DIAMETER (ID) AND OUTER DIAMETER (OD) DIMENSIONS OF THE PROWLER 14 MICROCATHETER WERE MEASURED AND CONFIRMED TO BE WITHIN SPECIFICATIONS. THE PREMATURE DETACHMENT DOCUMENTED IN THE COMPLAINT COULD BE THE RESULT OF THE STRETCHED CONDITION NOTED ON THE EMBOLIC COIL DURING THE ANALYSIS. THE SOLDER JOINT WAS STILL ATTACHED TO THE REST OF THE DELIVERY SYSTEM. AS SUCH, THE COIL DID NOT PREMATURELY DETACH, IT WAS STRETCHED. THE PRIMARY FAILURE MODE APPEARS TO HAVE BEEN THAT THE STRETCH RESISTANT FIBER BROKE WHILE THE COIL WAS BEING STRETCHED, THEN THE COIL UNRAVELED AND PULLED FREE FROM THE SOLDER JOINT. COIL STRETCHING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) PROVIDE PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUES. STRETCHING CAN OCCUR DURING PROCEDURE HANDLING WHERE FORCE MAY HAVE BEEN INADVERTENTLY APPLIED. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. THE CUSTOMER COMPLAINT REGARDING RESISTANCE / FRICTION WAS CONFIRMED SINCE THE CONDITIONS ENCOUNTERED ON THE EMBOLIC COIL COMPONENT ARE SUSPECTED TO BE SECONDARY TO THE RESISTANCE FELT BETWEEN THE EMBOLIC COIL AND MICROCATHETER DURING THE PROCEDURE. HOWEVER, THE COMPLAINT DOCUMENTED THAT THE MICROCATHETER WAS NOT DAMAGED, AND THE LOCATIONS WHERE THE KINK AND COMPRESSED CONDITIONS WERE NOTED ON THE MICROCATHETER ARE NOT CONSISTENT WITH THE LOCATIONS WHERE THE EMBOLIC COIL WAS KNOTTED AND STUCK. IT IS POSSIBLE THAT SUCH DAMAGES OCCURRED DURING POST-OPERATIVE HANDLING WITH THE EMBOLIC COIL ALREADY STUCK AND STRETCHED / KNOTTED INSIDE THE MICROCATHETER. THE DISTAL END OF THE EMBOLIC COIL WAS FOUND TO BE STUCK AT A MORE DISTAL LENGTH THAN ANY OF THE DAMAGES NOTED ON THE MICROCATHETER, SUCH DAMAGES MIGHT HAVE PRECLUDED THE ADVANCEMENT OF THE EMBOLIC COIL. AN ASSIGNMENT OF A ROOT CAUSE REMAINS UNKNOWN; OTHER PROCEDURAL FACTORS NOT DESCRIBED WITHIN THE INFORMATION AVAILABLE MAY HAVE CONTRIBUTED TO THE ISSUE EXPERIENCED RATHER THAN THE MANUFACTURE OF THE DEVICE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10708) 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. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATIONS: ¿ IF REPOSITIONING OF THE MICROCOIL IS NECESSARY, CAREFULLY OBSERVE THE MOTION OF THE MICROCOIL WITH RESPECT TO THE DPU WIRE WHILE RETRACTING THE MICROCOIL UNDER FLUOROSCOPY. IF THE MICROCOIL MOVEMENT IS NOT ONE-TO-ONE WITH THE DPU WIRE, OR IF REPOSITIONING IS DIFFICULT, THE MICROCOIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE MICROCOIL SYSTEM. ¿ IF THE MICROCOIL IS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER, A MICROCOIL MAY STRETCH OR BREAK AS IT IS BEING WITHDRAWN. BY REPOSITIONING THE DISTAL TIP OF THE MICROCATHETER AT OR SLIGHTLY INSIDE THE OSTIUM (NECK) OF THE ANEURYSM, THE MICROCOIL MAY BE MORE EASILY FUNNELED BACK INTO THE MICROCATHETER. ¿ IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY THE CLEAR TAB IS UNLOCKED AND PULLED OUT FROM THE RE-SHEATHING TOOL APPROXIMATELY 1 IN. ¿ IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICROCOIL SYSTEM AND EXAMINE FOR DAMAGE. REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS, WITHDRAW, AND EXAMINE THE DELIVERY CATHETER SYSTEM. BASED ON THE MANUFACTURING DOCUMENTATION 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.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 20-APR-2022. [ADDITIONAL INFORMATION]: ON 20-APR-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE CHANGE IN TECHNIQUE (ANEURYSM CLIPPING) WAS DUE TO THE PREFERENCE OF THE PHYSICIAN. THE PHYSICIAN COULD NOT DO THE FULL EMBOLIZATION. THE VESSEL WAS NOT TORTUOUS. THE INFORMATION INDICATED THAT THERE WAS RESISTANCE ENCOUNTERED DURING THE ADVANCEMENT OF THE COIL DELIVERY SYSTEM THROUGH THE CONCOMITANT MICROCATHETER, A 150CM X 50CM PROWLER 14 MICROCATHETER (606151FX / 30289569); THE RESISTANCE WAS FIRST FELT INSIDE THE MICROCATHETER AT THE MID-SECTION. THE DEVICE WAS STUCK. THE EMBOLIC COIL BECAME PREMATURELY DETACHED AT THE DETACHMENT ZONE ON THE DEVICE POSITIONING UNIT; IT DID NOT BECOME SEPARATED INTO TWO OR MORE PIECES. THE INFORMATION INDICATED THAT THE CONCOMITANT MICROCATHETER WAS SUCCESSFULLY USED WITH OTHER DEVICES PRIOR TO THE ENCOUNTERED RESISTANCE. THE MICROCATHETER WAS USED WITH A 4MM X 8CM DELTAXSFT (DLX100408 / 30607239), AND A 3MM X 10CM TARGET 360 ULTRA COIL (STRYKER). THE CONCOMITANT MICROCATHETER WAS NOT DAMAGED DURING THE MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE COIL ADVANCEMENT. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. ANOTHER 150CM X 50CM PROWLER 14 MICROCATHETER (606151FX / 30289569) WAS USED TO COMPLETE THE PROCEDURE. 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.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 19-APR-2022. ADDITIONAL INFORMATION: ON 19-APR-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PHYSICIAN READ THE INSTRUCTIONS FOR USE (IFU); THE IFU DOES CLEARLY DESCRIBE HOW TO USE THE MEDICAL DEVICE AND THE PHYSICIAN HAVE BEEN TRAINED IN ITS USE. THE ADDITIONAL INFORMATION ALSO INCLUDED THE OBSERVATIONS FROM THE PHYSICIAN: ¿FROM THE BEGINNING THE DOCTOR WAS GIVEN A PRESENTATION FOR THE HANDLING OF THE COIL AND WE TOOK THE USE OF THE VIDEOS, AND IN MANY CASES WHEN THE COIL IS SHEATHED IT DOES NOT PRESENT A PROBLEM. THE SAME STEPS ARE ALWAYS PERFORMED IT APPEARS THAT THE EVENT OF HYPOTUBE BREAKS AND WE HAVE SUPPORTED THE PHYSICIAN TO REVIEW THE PROCESS DURING THE PROCEDURE. AT THE VISIT OF THE BRAND SPECIALIST THE DOCTOR COMMENTED IN DETAIL ABOUT THIS FAILURE AND WENT THROUGH THE STEPS, WHERE IT WAS CLARIFIED THAT THE DOCTOR WAS DOING THE PROCESS AS IS FOR THE RECOVERY OF THE COIL, AND IT WAS NOT POSSIBLE TO EXPLAIN CONCLUSIVELY WHAT WAS GOING ON.¿ 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.
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA), BETWEEN THE COMMUNICATING SEGMENT AND THE CAROTID ARTERY, THE DEVICE WAS PURGED AND INSERTED INTO THE MICROCATHETER HUB. THE 4MM X 8CM GALAXY G3 XSFT COIL (GLX120408 / K10708) WAS ADVANCED, BUT THE DEVICE WAS NOT OBSERVED / SEEN IN FLUOROSCOPY. AS A RESULT, THE MICROCATHETER WAS COMPLETELY WITHDRAWN AND THE GUIDEWIRE WITHOUT THE CORRESPONDING COIL WAS OBSERVED. SUBSEQUENTLY, IT WAS VERIFIED UNDER FLUOROSCOPY THAT THE COIL WAS RELEASED IN THE MICROCATHETER WHILE IT WAS BEING ADVANCED. THE MICROCATHETER WAS CHANGED AND OTHER COILS WERE USED. ANEURYSM CLIPPING WAS REQUIRED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1271610 | GALAXY G3 XSFT 4MM X 8CM | NEUROVASCULAR EMBOLIZATION DEVICE | KRD | MEDOS INTERNATIONAL SARL | GLX120408 | K10708 | 10886704077732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | PRESHAPED PROWLER14 45TIP 2MRK. |