JADE 14 OTW PTA BALLOON DILATATION CATHETER

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESION IN AN UNSPECIFIED RIGHT LOWER EXTREMITY ARTERY. DURING THE PROCEDURE VIA COMMON FEMORAL ARTERY ACCESS THE TIP OF THE 6.0MM X 80MM JADE 14 PTA OTW BALLOON FRACTURED. SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE BALLOON TIP. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026: "IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, MILD TORTUOUS, 90% STENOSED LESION IN RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) VIA COMMON FEMORAL ARTERY ACCESS. DURING THE PROCEDURE THE TIP OF THE 6.0MM X 80MM JADE 14 PTA OTW BALLOON FRACTURED UPON REMOVAL OF THE BALLOON FROM THE SHEATH AND CAME OFF INSIDE THE DISTAL SFA STENT. SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE BALLOON TIP BUT WAS NOT COMPLETELY SUCCESSFUL. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND DISCHARGED AS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED. Q1. ANATOMICAL INFORMATION? (VESSEL / LOCATION / TORTUOSITY / CALCIFICATION / STENOSIS % / ETC.) PLEASE PROVIDE REASON IF UNAVAILABLE (HOSPITAL POLICY, ETC.) A1. RIGHT SFA, DISTAL RIGHT SFA HEAVILY CALCIFIED, MILD TORTUOSITY AND 90% STENOSIS Q2. IS THERE ANY INDICATION AS TO HOW THE FRACTURE OCCURRED? A2. UPON REMOVAL OF THE BALLOON FROM THE SHEATH THE TIP OF THE BALLOON CAME OFF INSIDE THE DISTAL SFA STENT. Q3. WAS THE SURGERY TO REMOVE THE COMPONENT COMPLETELY SUCCESSFUL? A3. NO. Q4. WHAT WAS THE PATIENT'S STATUS AFTER THE SURGERY (STABLE, DISCHARGED AS PLANNED, ETC.) A4. STABLE, PATIENT DISCHARGED AS PLANNED. Q5. REASON THE JADE BALLOON IS NOT RETURNING? (DISCARDED, HELD BY ACCOUNT, ETC.) A5. HELD BY ACCOUNT.