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

Model Number	H74939419501010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 - age at time of event: 83 years old at the time of study enrollment.\ a4 - weight: 89.1 kg.
Event or Problem Description
It was reported that dissection occurred requiring additional intervention.\ \ on (b)(6) 2026, the subject was enrolled in a clinical study.The target lesion was located in the distal superficial femoral artery of left leg.A 5.0 x 100mm, 135cm ranger drug coated balloon was inflated once at 6 atmospheres for 180 seconds.However, during the index procedure, a dissection was observed.An eluvia stent was placed.On the same day, the event was considered resolved.

• 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: 50762321
• Report Number: 2124215-2026-48982
• Device Sequence Number: 15806398
• Product Code: ONU
• UDI-Device Identifier: 08714729975984
• UDI-Public: (01)08714729975984(17)290128(10)993H26
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 09/14/2026

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: H74939419501010
• Device Catalogue Number: H74939419501010
• Device Lot Number: 00993H26
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 01/29/2026
• 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