MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ATHLETIS?; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939347050470
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 - age at time of event: 83 years old at the time of study enrollment.
Event or Problem Description
It was reported that dissection of type c was noted.The subject was enrolled into clinical study on (b)(6) 2025, and the index procedure was performed on the same day.During the index procedure, anti-coagulation therapy was administered.The target lesion was located in the left arm swing point with 4.40 mm reference vessel diameter, 52.23 mm length and 61% stenosis with no calcification.Pre-dilatation was performed using 5 mm x 40 mm boston scientific athletis balloon with residual stenosis of 25%.The target lesion was treated with 5 mm x 80 mm ranger drug coated balloon, study device.Post procedure, the residual stenosis was 25%.Index core lab angiography findings dated 06-jun-2025 revealed that the target lesion was located in the anastomosis and swing point, with 4.3 mm reference vessel diameter, 39.76 mm length, and 62.79% diameter stenosis.Dissection of type c was noted after pre-dilatation using 5 mm x 40 mm boston scientific athletis balloon.Post test device usage (ranger drug coated balloon), the diameter stenosis was noted to be 4.76% with dissection of type c unchanged.There was minimal residual dissection on final.Of note, as per site index procedure form no dissection was noted after pre-dilatation and test device usage.Post index procedure, avf functional assessment revealed flow volume (fv) of 388 ml/min, resistance index (ri) of 0.680, systolic blood pressure of 153 mmhg, and diastolic blood pressure of 53 mmhg.Post procedure, the subject was advised to continue ongoing aspirin, prasugrel and anticoagulant medication therapy.On (b)(6) 2025, the subject had first successful hemodialysis performed after index procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 83 years old at the time of study enrollment.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 ranger 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 known inherent risk of device.
Event or Problem Description
It was reported that dissection of type c was noted.The subject was enrolled into clinical study on (b)(6) 2025, and the index procedure was performed on the same day.During the index procedure, anti-coagulation therapy was administered.The target lesion was located in the left arm swing point with 4.40 mm reference vessel diameter, 52.23 mm length and 61% stenosis with no calcification.Pre-dilatation was performed using 5 mm x 40 mm boston scientific athletis balloon with residual stenosis of 25%.The target lesion was treated with 5 mm x 80 mm ranger drug coated balloon, study device.Post procedure, the residual stenosis was 25%.Index core lab angiography findings dated (b)(6) 2025 revealed that the target lesion was located in the anastomosis and swing point, with 4.3 mm reference vessel diameter, 39.76 mm length, and 62.79% diameter stenosis.Dissection of type c was noted after pre-dilatation using 5 mm x 40 mm boston scientific athletis balloon.Post test device usage (ranger drug coated balloon), the diameter stenosis was noted to be 4.76% with dissection of type c unchanged.There was minimal residual dissection on final.Of note, as per site index procedure form no dissection was noted after pre-dilatation and test device usage.Post index procedure, avf functional assessment revealed flow volume (fv) of 388 ml/min, resistance index (ri) of 0.680, systolic blood pressure of 153 mmhg, and diastolic blood pressure of 53 mmhg.Post procedure, the subject was advised to continue ongoing aspirin, prasugrel and anticoagulant medication therapy.On (b)(6) 2025, the subject had first successful hemodialysis performed after index procedure.

• Brand Name: ATHLETIS?
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24500147
• Report Number: 2124215-2026-11738
• Device Sequence Number: 9960709
• Product Code: LIT
• UDI-Device Identifier: 08714729973676
• UDI-Public: (01)08714729973676(17)280120(10)35666180
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H74939347050470
• Device Catalogue Number: H74939347050470
• Device Lot Number: 0035666180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 01/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: Asian