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

Model Number	H74939419502010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion, exhibiting 90% or greater stenosis, was located in the mildly tortuous and severely calcified distal superficial femoral artery extending to the popliteal artery.A 5.0 x 200 mm, 150 cm ranger balloon catheter was advanced for dilatation.During the initial inflation at 13 atmospheres, the balloon ruptured.The device was removed without difficulty, and the procedure was successfully completed using an alternate device.No patient complications were reported as a result of this event.

• 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: 23548287
• Report Number: 2124215-2025-82869
• Device Sequence Number: 13164190
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: (01)08714729976042(17)280615(10)6613H25
• 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): 11/13/2025

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: H74939419502010
• Device Catalogue Number: H74939419502010
• Device Lot Number: 06613H25
• 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: 11/13/2025
• Date Device Manufactured: 06/16/2025
• 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