CHIKAI NEXUS 014

Additional Manufacturer Narrative

MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749. INVESTIGATION RESULT: THE REPORTED CHIKAI NEXUS 014 GUIDE WIRE WAS RETURNED FOR EVALUATION. THE RETURNED CHIKAI NEXUS 014 GUIDE WIRE WAS FOUND BENT AT APPROXIMATELY 90MM FROM THE WIRE TIP. LINEAR SCRATCH MARKS LIKELY CAUSED BY ABRASION LOAD WERE OBSERVED ON THE PTFE COATING AT APPROXIMATELY 200MM TO 600MM FROM THE PROXIMAL END. THE CORE WIRE WAS EXPOSED. NO ABNORMALITIES, SUCH AS ADHESION OF PEELED FRAGMENTS OR DAMAGE, WERE OBSERVED ON THE INSERTER. BASED ON KNOWN SIMILAR CASES, AN UNUSED TORQUE DEVICE WAS INTENTIONALLY TIGHTENED SLIGHTLY LOOSELY ONTO AN UNUSED CHIKAI NEXUS 014 GUIDE WIRE AND MOVED WHILE ROTATING SO THAT THE METAL WIRE-FIXING COMPONENT INSIDE THE TORQUE DEVICE ABRADED THE SHAFT SURFACE. THE PTFE COATING WAS THEN OBSERVED FOR PEELING, AND IT WAS FOUND THAT SCRATCHES SIMILAR TO THOSE ON THE RETURNED GUIDE WIRE WERE PRODUCED. LOT HISTORY RECORD REVIEW: LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. CONCLUSION (ROOT CAUSE): BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT HE PTFE COATING ON THE SUBJECT CHIKAI NEXUS 014 GUIDE WIRE MIGHT HAVE BEEN ABRADED AND DAMAGED DUE TO STRONG INTERFERENCE WITH THE METAL WIRE-FIXING COMPONENT INSIDE THE TORQUE DEVICE. CONSEQUENTLY, THE PTFE COATING OF THE GUIDE WIRE WAS SCRAPED OFF. ALTHOUGH IT WAS CONCLUDED THAT THE REPORTED EVENT WAS NOT ATTRIBUTED TO THE PRODUCT QUALITY, IT WAS CONCLUDED THAT THE PTFE COATING FRAGMENT LEFT IN SITU COULD NOT BE COMPLETELY RULED OUT AS THE COATING FRAGMENT WAS NOT RETURNED. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: {PRECAUTINS] FASTEN THE TORQUE DEVICE TO THE GUIDE WIRE FIRMLY SO THAT IT MAY NOT LOOSEN. TORQUE OPERATION WITH A LOOSE TORQUE DEVICE MAY CAUSE THE COATING TO COME OFF. WHEN CHANGING THE ATTACHMENT POSITION OF THE TORQUE DEVICE ON THE GUIDE WIRE, LOOSEN THE FASTENING OF THE TORQUE DEVICE BEFORE MOVING IT. [MALFUNCTION AND ADVERSE EFFECTS]. COATING DELAMINATION.

Description of Event or Problem

IT WAS REPORTED THAT, COIL EMBOLIZATION WAS PERFORMED FOR A CEREBRAL ANEURYSM AT THE INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY JUNCTION (IC-PC). AN ASAHI CHIKAI NEXUS 014 GUIDE WIRE WAS INSERTED INTO A CONCOMITANT MICROCATHETER AND USED. WHEN THE SUBJECT CHIKAI NEXUS 014 GUIDE WIRE WAS WITHDRAWN THROUGH THE INSERTER, SOME OBJECT LIKELY SHAVINGS WERE FOUND ADHERED TO THE GUIDE WIRE. THE SUBJECT GUIDE WIRE WAS REMOVED, THE EMBOLIZATION WAS CONTINUED AND COMPLETED WITHOUT ANY PROBLEMS. IT WAS INFORMED THAT NO ABNORMALITY WAS NOTED IN THE PATIENT'S POSTOPERATIVE HEALTH CONDITION.