MUSTANG?

Additional Manufacturer Narrative

D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K): K141521, K141597. INVESTIGATION RESULTS: DEVICE TECHNICAL ANALYSIS: UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. THE RATED BURST PRESSURE FOR THIS DEVICE IS 20 ATMOSPHERES AS PER MUSTANG SPECIFICATION. THE RETURNED DEVICE WAS ATTACHED TO AN INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN DI WATER WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE LOCATED APPROXIMATELY 23MM DISTAL FROM THE PROXIMAL MARKERBAND. A VISUAL EXAMINATION OF THE MARKERBANDS IDENTIFIED NO ISSUES. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO KINKS OR DAMAGE TO THE SHAFT AND TO THE TIP. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.\ LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. RISK REVIEW: A REVIEW OF THE MUSTANG DEVICE CONFIRMED THAT THE REPORTED EVENT IS A KNOWN EVENT DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PATIENT CONDITION.

Description of Event or Problem

REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS HARDLY CALCIFIED ARTERIOVENOUS FISTULA. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE INFLATION AT NOMINAL ATMOSPHERES, A LEAKAGE OF RADIOCONTRAST WAS DETECTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.