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 Codes	Obstruction/Occlusion (2422); Restenosis (4576)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis occurred.Following the initial intervention performed on (b)(6) 2025, the patient demonstrated improvement, however, significant residual and recurrent disease persisted in the treated vascular segments.Despite successful recanalization and drug-coated balloon angioplasty of the right superficial femoral artery (sfa) and peroneal artery, subsequent noninvasive studies and clinical assessment prior to the second procedure on (b)(6) 2025, revealed flow-limiting stenoses in the right sfa, popliteal artery, and runoff vessels.During the repeat angiographic evaluation, intravascular ultrasound confirmed moderate to severe diffuse atherosclerotic disease, including interval progression and restenosis within previously treated segments.These findings necessitated additional endovascular intervention involving atherectomy and balloon angioplasty across multiple vascular levels.Collectively, the recurrence of clinically significant stenosis within a short interval following the prior procedure is consistent with restenosis.

• 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: 23620456
• Report Number: 2124215-2025-85528
• Device Sequence Number: 9032261
• Product Code: ONU
• UDI-Device Identifier: 08714729976028
• UDI-Public: (01)08714729976028(17)270311(10)2532H25
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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 Model Number: H74939419501510
• Device Catalogue Number: H74939419501510
• Device Lot Number: 02532H25
• 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: 10/27/2025
• Initial Report FDA Received Date: 11/21/2025
• Date Device Manufactured: 03/11/2025
• 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: 86 YR
• Patient Sex: Unknown