MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Ranger?; Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Model Number	H74939419601510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Obstruction/Occlusion (2422)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that gangrene of the right 5th toe occurred with occlusion of the right sfa treatment site, requiring additional intervention.The subject underwent treatment with the ranger drug-coated balloon on (b)(6) 2026 as a part of the clinical trial.The target lesion #001 was in the right proximal superficial femoral artery (sfa) with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 10 mm lesion length and 80 % stenosis and classified as transatlantic intersociety consensus (tasc) ii b lesion.Prior to the treatment of target lesion with the study device, atherectomy was performed with 1.5 mm x 145 mm diamondback atherectomy device and pre-dilation was performed using 5 mm x 220 mm sterling balloon.Treatment of target lesion was performed by dilation using 6 mm x 200 mm ranger drug coated balloon, study device.The balloon was inflated once to a maximum inflation pressure of 8 atmospheres for 3 seconds.Following treatment, the final residual stenosis was noted to be 35%.The target lesion #002 was in the right distal superficial femoral artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 14 mm lesion length and 100 % stenosis and classified as tasc ii c lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed using 5 mm x 220 mm sterling balloon.Treatment of target lesion was performed by dilation using 6 mm x 150 mm ranger drug coated balloon, study device.The balloon was inflated once to a maximum inflation pressure of 12 atmospheres for 3 seconds.Following treatment, the final residual stenosis was noted to be 35%.On (b)(6) 2026, the subject was discharged from hospital.On (b)(6) 2026, 13 days post index procedure, the subject was reported with an occluded right sfa treatment site and gangrene of the right 5th toe.In response to the event, medications were given or adjusted, the hospitalization was prolonged, and the subject underwent vascular bypass surgery and an angiogram medical procedure.The outcome of the event is ongoing.
Additional Manufacturer Narrative
A2 - age at time of event: 74 years old at the time of study enrollment.A4 - weight: 83.4 kg.

• Brand Name: Ranger?
• Common Device Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50779600
• Report Number: 2124215-2026-49247
• Device Sequence Number: 9762184
• Product Code: ONU
• UDI-Device Identifier: 08714729976189
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: H74939419601510
• Device Catalogue Number: H74939419601510
• Device Lot Number: 06427H25
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 06/16/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: Asian