MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER?; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	H74939419600810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject (b)(6), 54 years old at the time of enrollment.
Event or Problem Description
It was reported that vessel dissection occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2025 as a part of the clinical trial.The target lesion #001 was in the left mid superficial femoral artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with 60 mm lesion length with 76% stenosis and was classified as tasc ii class b lesion.Prior to target lesion treatment with study device, atherectomy was performed using 1.7 mm turbo elite atherectomy device.Treatment of target lesion was performed by dilation using 6 mm x 80 mm ranger drug coated balloon, study device.Following procedure, 6 mm x 80 mm non - bsc drug eluting stent was placed, and the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2025, on the same day of index procedure, during the treatment of target lesion, long segment dissection of grade b was noted in left mid superficial femoral artery due to 6 mm x 80 mm ranger drug coated balloon.The site confirmed through query response that atherectomy procedure performed prior to ballooning caused the vessel more prone to dissection.In response to dissection, 6 mm x 80 mm non-boston scientific (bsc) drug eluting stent was placed in left mid superficial femoral artery.Final arteriogram demonstrated resolution of the stenosis and patent runoff.On the same day, the event was considered to be resolved, and the subject was prescribed dual antiplatelet therapy.
Additional Manufacturer Narrative
The subject(b)(6), 54 years old at the time of enrollment.Device history records (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 risk review performed for the ranger dcb 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 benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was known inherent risk of device.
Event or Problem Description
It was reported that vessel dissection occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2025 as a part of the clinical trial.The target lesion #001 was in the left mid superficial femoral artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with 60 mm lesion length with 76% stenosis and was classified as tasc ii class b lesion.Prior to target lesion treatment with study device, atherectomy was performed using 1.7 mm turbo elite atherectomy device.Treatment of target lesion was performed by dilation using 6 mm x 80 mm ranger drug coated balloon, study device.Following procedure, 6 mm x 80 mm non - bsc drug eluting stent was placed, and the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2025, on the same day of index procedure, during the treatment of target lesion, long segment dissection of grade b was noted in left mid superficial femoral artery due to 6 mm x 80 mm ranger drug coated balloon.The site confirmed through query response that atherectomy procedure performed prior to ballooning caused the vessel more prone to dissection.In response to dissection, 6 mm x 80 mm non-boston scientific (bsc) drug eluting stent was placed in left mid superficial femoral artery.Final arteriogram demonstrated resolution of the stenosis and patent runoff.On the same day, the event was considered to be resolved, and the subject was prescribed dual antiplatelet therapy.

• 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): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22680504
• Report Number: 2124215-2025-50745
• Device Sequence Number: 15814459
• Product Code: ONU
• UDI-Device Identifier: 08714729976127
• UDI-Public: (01)08714729976127(17)261025(10)11149H24
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: H74939419600810
• Device Catalogue Number: H74939419600810
• Device Lot Number: 11149H24
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 10/25/2024
• 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 Age: 54 YR
• Patient Sex: Male