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

Model Number	H74939419600410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis occurred requiring additional intervention.The target lesion was located in the right arm av fistula outflow vein (basilic vein).On mar.31, 2026, two ranger paclitaxel-coated pta balloon catheters were selected for use in a clinical study: a 6.0 x 40 mm, 135 cm ranger balloon, which was inflated once at 9 atmospheres for 150 seconds, and a 5.0 x 40 mm, 135 cm ranger balloon, which was inflated once at 8 atmospheres for 150 seconds.On (b)(6), 2026, restenosis of the right av fistula outflow vein occurred, and the patient underwent an angioplasty procedure.On (b)(6), 2026, the event was considered resolved.
Additional Manufacturer Narrative
A4 - weight: 68.4 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: 50587895
• Report Number: 2124215-2026-46543
• Device Sequence Number: 13184349
• Product Code: ONU
• UDI-Device Identifier: 08714729976080
• UDI-Public: (01)08714729976080(17)280731(10)8283H25
• 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): 10/02/2026

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: H74939419600410
• Device Catalogue Number: H74939419600410
• Device Lot Number: 08283H25
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 08/01/2025
• 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: 83 YR
• Patient Sex: Unknown