OPTOWIRE III

Additional Manufacturer Narrative

WIRE WAS RETURNED, RECEIVED ON OCTOBER 30TH AND INSPECTED UPON RECEPTION. INVESTIGATION OF THE RETURNED OPTOWIRE SHOWED THAT THE GUIDEWIRE FRACTURED AT 30CM FROM ITS DISTAL END, AT THE PROXIMAL WELD THAT CONNECTS THE SHAFT TO THE INTERMEDIATE SECTION. VISUAL INSPECTION OF THE WHOLE WIRE SHOWED A SIGNIFICANT CURVATURE STARTING AT ABOUT 125CM FROM THE EXTREMITY OF THE SHAFT. CURVATURE EXTENDS FOR ABOUT 13CM AND THE LAST 12CM OR SO OF THE WIRE, UP TO THE FRACTURE POINT, IS STRAIGHT. ZOOMED PHOTOS SHOWED BOTH FRACTURED SECTIONS OF THE WIRE. HEAT TREATMENT OF THE WELD REGION REQUIRED TO ACHIEVE DESIRED MECHANICAL RESISTANCE CHARACTERISTICS REGARDING RESISTANCE TO FRACTURE WAS PERFORMED. NO SIGNS OF TORSION ARE VISIBLE ON BOTH ENDS. NO EVIDENCE OF MANUFACTURING ISSUE OR MATERIAL DEFECT WAS OBSERVED. IT IS BELIEVED THAT THE WIRE ENTERED AN IMPORTANT CURVATURE ZONE IN THE BODY BASED ON THE CURVATURE OBSERVED ON THE WIRE. CONSIDERING THE LOCATION OF THE CURVATURE, WE CAN ASCERTAIN THAT THE PROXIMAL WELD WAS SUBJECTED TO IT AS IT PRECEDES THIS SECTION OF THE WIRE. REVIEW OF DEVICE HISTORY RECORDS CONFIRMED THAT THE OPTOWIRE III HAD BEEN RELEASED AS PER SPECIFICATION. BASED ON THE AVAILABLE EVENT INFORMATION, THE CAUSE OF THE FAILURE WAS LIKELY RELATED TO THE USAGE OF THE DEVICE BEYOND THE RECOMMENDATIONS PROVIDED IN THE INSTRUCTIONS FOR USE (IFU). USAGE OF THE OPTOWIRE OF IS RECOMMENDED WITH GUIDING CATHETER. AS PER IFU: ADVANCE THE OPTOWIRE THROUGH GUIDING CATHETER USING THE APPROPRIATE GUIDEWIRE INTRODUCER. ALL POTENTIAL RISKS ASSOCIATED WITH THE EVENT ARE DISCLOSED IN THE OPTOWIRE III INSTRUCTIONS FOR USE (IFU): IF RESISTANCE OCCURS AND THE CAUSE OF RESISTANCE CANNOT BE DETERMINED, DO NOT MOVE OR TORQUE THE OPTOWIRE. STOP THE PROCEDURE, DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE ACTION. OPTOWIRE SHOULD BE MANIPULATED ONLY UNDER FLUOROSCOPY. CARE SHOULD BE TAKEN WHEN MANIPULATING A GUIDEWIRE INSIDE A VESSEL DURING DEVICE PLACEMENT AND REMOVAL. OBSERVE OPTOWIRE MOVEMENT IN THE VESSELS. BEFORE AN OPTOWIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED UNDER FLUOROSCOPY. DO NOT TORQUE AN OPTOWIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, VESSEL TRAUMA MAY OCCUR. NEVER ADVANCE AN OPTOWIRE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE REASON FOR THE RESISTANCE UNDER FLUOROSCOPY. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE WIRE AND/OR TO THE VESSEL. IF RESISTANCE OCCURS AND THE CAUSE OF RESISTANCE CANNOT BE DETERMINED, DO NOT MOVE OR TORQUE THE OPTOWIRE. STOP THE PROCEDURE, DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE ACTION. DO NOT USE THE OPTOWIRE IF ANY PORTION OF THE DEVICE OR PACKAGING APPEARS DAMAGED, IF ANY PORTION OF THE STERILE POUCH HAS BEEN OPENED OR IF PRODUCT IS EXPIRED. CONFIRM THE COMPATIBILITY OF THE GUIDEWIRE DIAMETER WITH THE INTERVENTIONAL DEVICE BEFORE ACTUAL USE.

Description of Event or Problem

THE WIRE BROKE IN TWO WHILE BEING IN THE PATIENT, 30 CM. IT WAS A REGULAR PROCEDURE, THE INCIDENT HAPPENED WHILE THE WIRE WAS INSIDE THE GUIDING CATHETER, NO EXTRA FORCES WERE USED. NO DISTAL PROTECTION WAS USED. NO INJURY TO PATIENT. ADDITIONAL INFORMATION: THE GUIDEWIRE BROKE APPROXIMATELY 30 CM FROM THE TIP AND THE PROXIMAL SEGMENT OF THE BROKEN 30 CM WIRE WAS LOCATED INSIDE THE LUMEN OF THE GUIDING CATHETER. THE DOCTOR DECIDED TO USE A REGULAR BALLOON TO RETRIEVE THE GUIDEWIRE. THE BALLOON WAS SLIGHTLY INFLATED TO CATCH THE WIRE AND PULL IT OUT TOGETHER WITH THE BALLOON. THE PATIENT WAS FINE. THERE WAS NO DISTAL DISSECTION OR PERFORATION.