JADE 14 OTW PTA BALLOON DILATATION CATHETER

Description of Event or Problem

IT WAS REPORTED A JADE 3.0 MM X 60 MM BALLOON WAS ADVANCED INTO THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE BALLOON WAS INFLATED AND THE TREATMENT WAS COMPLETED. THE BALLOON WAS DEFLATED AND ATTEMPTED TO BE REMOVED. DURING REMOVAL, THE BALLOON PORTION OF THE DEVICE SEPARATED FROM THE SHAFT UPON REMOVAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA E-MAIL ON 2026/6/10: 1. THE BALLOON PORTION OF THE CATHETER SEPARATED AT THE PROXIMAL BALLOON ATTACHMENT POINT. 2. THE BALLOON REMAINED IN THE PATIENT POPLITEAL ARTERY. THE PATIENT WAS SENT FOR SURGICAL REMOVAL. 3. LOT NUMBER 5855062509.