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

Model Number	H74939419501510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that target lesion revascularization occurred requiring additional intervention.The target lesions were located in the left common femoral artery, proximal superficial femoral artery, distal superficial femoral artery, and proximal popliteal artery.On (b)(6) 2025, a 6 x 150 mm, 150 cm ranger drug-coated balloon was used to treat target lesion #001, and a 5 x 150 mm, 150 cm ranger drug-coated balloon was used to treat target lesion #002.Both balloons were inflated once at 10 atmospheres for 180 seconds.On (b)(6) 2026, the patient underwent an interventional revascularization procedure consisting of shockwave therapy, rotarex atherectomy, and drug-coated balloon angioplasty and the event was considered resolved on (b)(6) 2026.
Event or Problem Description
It was reported that target lesion revascularization occurred requiring additional intervention.The target lesions were located in the left common femoral artery, proximal superficial femoral artery, distal superficial femoral artery, and proximal popliteal artery.On (b)(6) 2025, a 6 x 150 mm, 150 cm ranger drug-coated balloon was used to treat target lesion #001, and a 5 x 150 mm, 150 cm ranger drug-coated balloon was used to treat target lesion #002.Both balloons were inflated once at 10 atmospheres for 180 seconds.On (b)(4) 2026, the patient underwent an interventional revascularization procedure consisting of shockwave therapy, rotarex atherectomy, and drug-coated balloon angioplasty and the event was considered resolved on (b)(6) 2026.
Additional Manufacturer Narrative
A4: weight: 114.8 kg.
Additional Manufacturer Narrative
A4: weight: 114.8 kg investigation results: device history records (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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 adverse event related to patient condition.

• 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: 50351076
• Report Number: 2124215-2026-44884
• Device Sequence Number: 15999849
• Product Code: ONU
• UDI-Device Identifier: 08714729976028
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/28/2026

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: H74939419501510
• Device Catalogue Number: H74939419501510
• Device Lot Number: 03907H25
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 04/16/2025
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male