GALAXY G3 MINI 3MM X 6CM
Report
- Report Number
- 3008114965-2021-00527
- Event Type
- Malfunction
- Date Received
- November 3, 2021
- Date of Event
- October 18, 2021
- Report Date
- January 12, 2022
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- KRD
- UDI-DI
- 10886704080336
- PMA / PMN Number
- K171862
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3.00MM X 6.00CM GALAXY G3 MINI COIL (GLM930060 / K10504) WAS THE SECOND COIL USED; THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. THE EMBOLIC COIL WAS OBSERVED TO BE STRETCHED DURING THE INSPECTION AFTER REMOVAL. THE PHYSICIAN USED ANOTHER ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE / COMPLICATION. THE COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 3.00MM X 6.00CM GALAXY G3 MINI COIL WAS RECEIVED. VISUAL INSPECTION WAS PERFORMED. THE CORE WIRE WAS OBSERVED KINKED. THE INTRODUCER WAS SPLIT AND THE EMBOLIC COIL WAS PROTRUDING FROM THE INTRODUCER. NO OTHER DAMAGES NOR ANOMALIES WERE OBSERVED DURING THE VISUAL INSPECTION. MICROSCOPIC INSPECTION WAS PERFORMED. UNDER MAGNIFICATION, THE EMBOLIC COIL WAS OBSERVED DAMAGED AND STRETCHED IN SECTIONS WERE OBSERVED ALONG THE COIL. THE KINKED PORTION OF THE CORE WIRE WAS OBSERVED TWISTED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE EMBOLIC COIL PROTRUDING FROM THE INTRODUCER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10504) 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. THE COMPLAINT DOCUMENTED THAT DURING THE PROCEDURE, THE 3.00MM X 6.00CM GALAXY G3 MINI COIL WAS THE SECOND COIL USED; IT COULD NOT BE ADVANCED NOR RETRIEVED WHICH PROMPTED THE PHYSICIAN TO REMOVE THE COIL AND THE CONCOMITANT MICROCATHETER TOGETHER. AFTER REMOVAL, INSPECTION OF THE COMPLAINT DEVICE WAS PERFORMED AND THE EMBOLIC COIL WAS OBSERVED STRETCHED. THE RETURNED DEVICE UNDERWENT VISUAL AND MICROSCOPIC INSPECTION. VISUAL INSPECTION NOTED THE EMBOLIC COIL COMPONENT PROTRUDING FROM THE INTRODUCER WHICH WAS OBSERVED SPLIT. THE CORE WIRE WAS KINKED AND CONFIRMED TO BE TWISTED DURING THE MICROSCOPIC INSPECTION. MICROSCOPIC INSPECTION REVEALED A DAMAGED EMBOLIC COIL THAT WAS ALSO STRETCHED ALONG ITS ENTIRE LENGTH. THE CONDITION OF THE RETURNED DEVICE PRECLUDED FUNCTIONAL TESTING. THE OBSERVED DAMAGES COULD BE THE RESULT OF DEVICE MANEUVERING AND INADVERTENTLY APPLIED FORCE DURING THE ATTEMPT TO ADVANCE / RETRIEVE THE COIL. BASED ON THE OBSERVED DAMAGES, THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING RECOMMENDATIONS: ¿ DO NOT FASTEN THE RHV VALVE TOO TIGHTLY AROUND THE INTRODUCER SHEATH SINCE EXCESSIVE PRESSURE MAY CAUSE DAMAGE TO THE INTRODUCER SHEATH AND/OR THE MICROCOIL AS IT IS ADVANCED INTO THE INFUSION MICROCATHETER. ADDITIONALLY, IF THE INTRODUCER TIP AND MICROCATHETER HUB ARE MISALIGNED, DAMAGE MAY OCCUR TO THE MICROCOIL AS IT PASSES THROUGH THIS TRANSITION. ¿ IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY THE LOCKING MECHANISM, OR CLEAR TAB IS UNLOCKED AND PULLED OUT FROM THE RESHEATHING TOOL APPROXIMATELY 1 IN (2-3 CM). ¿ IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM THROUGH THE INTRODUCER, OPEN THE RHV MAIN VALVE, AND PARTIALLY WITHDRAW THE DISTAL END OF THE INTRODUCER TO EXPOSE ITS TIP WITHIN THE RHV. TIGHTEN THE RHV MAIN VALVE AND FLUSH THE Y-CONNECTOR OF THE RHV WITH STERILE SALINE AND VERIFY THAT FLUID EXITS THE SLIT IN THE CLEAR PORTION OF THE INTRODUCER. AFTER FLUSHING, REINSERT THE INTRODUCER INTO THE INFUSION CATHETER HUB AS DESCRIBED IN ¿MICROCOIL PLACEMENT¿ SECTION ABOVE. ¿ 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. UPDATED SECTIONS: B.4, 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 THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 04-JAN-2022. 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.
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. PROCODE IS KRD/HCG. THE NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10504) 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.
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3.00MM X 6.00CM GALAXY G3 MINI COIL (GLM930060 / K10504) WAS THE SECOND COIL USED; THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. THE EMBOLIC COIL WAS OBSERVED TO BE STRETCHED DURING THE INSPECTION AFTER REMOVAL. THE PHYSICIAN USED ANOTHER ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE / COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1646213 | GALAXY G3 MINI 3MM X 6CM | NEUROVASCULAR EMBOLIZATION DEVICE | KRD | MEDOS INTERNATIONAL SARL | GLM930060 | K10504 | 10886704080336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |