MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER?; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	H74939419500610
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 5.0 x 60mm, 135cm ranger drug-coated balloon was advanced for dilation.However, during the first inflation at 6 atmospheres for 10 seconds, the balloon ruptured.The device was removed without any problem using the normal method, and the procedure was completed with a different device.There were no patient complications as a result of this event, and the patient was in good condition post-procedure.

• 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 ; 7634941632
• MDR Report Key: 25064563
• Report Number: 2124215-2026-23871
• Device Sequence Number: 10132063
• Product Code: ONU
• UDI-Device Identifier: 08714729975946
• UDI-Public: (01)08714729975946(17)280731(10)8281H25
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2026

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: H74939419500610
• Device Catalogue Number: H74939419500610
• Device Lot Number: 08281H25
• 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: 04/17/2026
• Initial Report FDA Received Date: 05/04/2026
• 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
• Patient Sex: Unknown