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

Model Number	H74939419501510
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5.0 x 150mm, 150cm ranger drug coated balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 6 atmospheres for 20 seconds.The device was removed without any problem, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5.0 x 150mm, 150cm ranger drug coated balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 6 atmospheres for 20 seconds.The device was removed without any problem, and the procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that no rupture has occurred.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.B5.Describe event or problem: added information, based on additional information.E1 - initial reporter address 1: (b)(6).

• 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: 25065043
• Report Number: 2124215-2026-23884
• Device Sequence Number: 21189037
• Product Code: ONU
• UDI-Device Identifier: 08714729976028
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939419501510
• Device Catalogue Number: H74939419501510
• Device Lot Number: 12332H25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 11/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Balloon Catheter - Shiden.; Guidewire - Asahi Intec.; Inflation Device - GM30.; Introducer Sheath - TERUMO.; Micro Catheter - Ichibanyari
• Patient Sex: Unknown