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

Model Number	H74939419602010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 - age at time of event: 87 years old at the time of study enrollment.E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that dissection was noted requiring intervention.On (b)(6) 2025, the subject underwent treatment with the eluvia drug-eluting stent and ranger drug coated balloons as a part of the clinical trial.The target lesion #001 was in the left proximal superficial femoral artery and left mid superficial femoral artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 100 mm lesion length with 80% stenosis and was classified as tasc ii b lesion.Prior to target lesion treatment with study device, atherectomy was performed using 2.2 mm x 3000 mm phoenix atherectomy device.Treatment of target lesion was performed by dilation using 6 mm x 200 mm ranger drug-coated balloon and placement of 7 mm x 40 mm eluvia drug eluting stent study devices.Following treatment was performed by placement of 5.5 mm x 150 mm supera bare metal stent and balloon dilation using 5.5 mm x 20 mm armada pta balloon.Post procedure, the final residual stenosis was noted to be 0%.The target lesion #002 was in the left distal popliteal artery with 4 mm proximal reference vessel diameter and 4 mm distal reference vessel diameter with 10 mm lesion length with 80% stenosis and was classified as tasc ii b lesion.Prior to target lesion treatment with study device, atherectomy was performed using 2.2 mm x 3000 mm phoenix atherectomy device.Treatment of target lesion was performed by dilation using 4 mm x 60 mm ranger drug-coated balloon study device.Following treatment, the final residual stenosis was noted to be 0%.On the same day of index procedure, during the treatment of target lesion #001, dissection of grade a was noted in the left mid superficial femoral artery due to 6 mm x 200 mm ranger drug coated balloon.In response to dissection, a 5.5 mm x 150 mm non-boston scientific stent was placed in the mid superficial femoral artery which was post dilated using 5.5 mm x 20 mm armada ballon.Post treatment, the final residual stenosis was noted to be 0%.On the same day, the event was considered to be resolved, and the subject was discharged from the hospital on 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23477696
• Report Number: 2124215-2025-77853
• Device Sequence Number: 10329991
• Product Code: ONU
• UDI-Device Identifier: 08714729976202
• UDI-Public: (01)08714729976202(17)260723(10)7545H24
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• 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
• Report Date (Section B): 11/05/2025

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 Expiration Date: 07/23/2026
• Device Model Number: H74939419602010
• Device Catalogue Number: H74939419602010
• Device Lot Number: 07545H24
• 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: 10/07/2025
• Initial Report FDA Received Date: 11/05/2025
• Date Device Manufactured: 07/23/2024
• 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 Sex: Female
• Patient Race: White