ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR ANALYSIS ON JUNE 30, 2017. THE ANALYSIS HAS NOT YET BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative

CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A BASILAR ARTERY ANEURYSM, A G2TDL COMPLEX FILL COIL (641CF0721/ S12761) FAILED TO DETACH WITH USING CABLES WITH DIFFERENT LOTS AND A DETACHMENT CONTROL BOX (B)(4). THE COIL WAS REMOVED FROM THE MICROCATHETER WITHOUT DIFFICULTY AND THE PROCEDURE WAS CONTINUED WITHOUT CONSEQUENCE FOR THE PATIENT; HOWEVER, THE PROCEDURE WAS DELAYED AND RISKIER DUE TO THE EVENT AND THE PROCEDURE WAS DELAYED 20 MINUTES. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED AND THE SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS FIT PROPERLY WITHOUT NEED FOR EXCESSIVE FORCE. IT WAS REPORTED THAT PRODUCT WOULD BE RETURNED FOR ANALYSIS. THE DEVICE WAS RETURNED TANGLED WITH THE EMBOLIC COIL TYING SECTIONS OF THE DPU CORE WIRE TOGETHER. THE AREA WAS MANUALLY UNTIED. THE RESHEATHING TOOL WAS ADVANCED TO THE PROXIMAL END OF THE GREEN INTRODUCER AND THE TRANSLUCENT INTRODUCER SHEATH DID NOT COVER ANY PART OF THE DPU. THE WIRE ALSO KINKED AT THE JUNCTION BETWEEN THE DPU WIRE AND PROXIMAL CONNECTOR HUB WHERE THE WIRE ENTERS THE HUB. THERE WAS A BEND IN THE DPU CORE WIRE APPROXIMATELY 17.5 CM FROM THE DISTAL TIP END OF THE DPU. THE DEVICE¿S RESISTANCE READ 35.7 OHMS USING A MULTIMETER WHICH IS OUTSIDE THE SPECIFICATION OF 48.0 TO 56.0 OHMS. USING A LAB SAMPLE DETACHMENT CONTROL BOX AND CONTROL CABLE CONNECTED TO THE RETURNED MICROCOIL SYSTEM, THE SYSTEM FAULT LIGHT ON THE DETACHMENT CONTROL BOX ILLUMINATED WHEN IT WAS POWERED ON. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT THAT THE COIL COULD NOT BE DETACHED WAS CONFIRMED. THE LIKELY CAUSE OF OUT OF SPECIFICATION RESISTANCE MEASUREMENT AND THE SYSTEM FAULT LIGHT ILLUMINATING ON THE DETACHMENT CONTROL BOX WHEN THE SYSTEM WAS CONNECTED IS MECHANICAL DAMAGE TO THE DEVICE. THE TWO KINKED SECTIONS ON THE DEVICE CORE WIRE INDICATE THAT EXTERNAL FORCE WAS APPLIED TO CAUSE THE WIRE TO BEND AND KINK. THE CIRCUMSTANCES THAT CAUSED THE WIRE KINK ARE UNKNOWN; HOWEVER, IT DID NOT OCCUR DURING MANUFACTURING BECAUSE THE CORE WIRE IS INSPECTED IN PROCESS FOR KINKS AND BENDS. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative

KRD/HCG. IT IS ANTICIPATED THAT THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem

AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A BASILAR ARTERY ANEURYSM, A G2TDL COMPLEX FILL COIL (641CF0721/ S12761) FAILED TO DETACH WITH USING CABLES WITH DIFFERENT LOTS AND A DETACHMENT CONTROL BOX (DCB00000500/C20654) . THE COIL WAS REMOVED FROM THE MICROCATHETER WITHOUT DIFFICULTY AND THE PROCEDURE WAS CONTINUED WITHOUT CONSEQUENCE FOR THE PATIENT; HOWEVER, THE PROCEDURE WAS DELAYED AND RISKIER DUE TO THE EVENT AND THE PROCEDURE WAS DELAYED 20 MINUTES. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED AND THE SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS FIT PROPERLY WITHOUT NEED FOR EXCESSIVE FORCE. IT WAS REPORTED THAT PRODUCT WOULD BE RETURNED FOR ANALYSIS.