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

Model Number	H74939419401010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: patient age 83 years old (at the time of enrollment).A4: weight: 69.2 kg.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported gangrene of right foot occurred requiring intervention.The subject was enrolled in a clinical study on (b)(6) 2024.The target lesion was treated with a 4.0 x 100mm, 135cm ranger drug-coated balloon followed by a 5.0 x 150mm, 150 cm ranger drug-coated balloon.The 4.0 x 100mm, 135cm ranger was inflated once to a maximum inflation pressure 16 atmospheres for 180 seconds.The 5.0 x 150mm, 150 cm ranger was inflated once to a maximum inflation pressure 14 atmospheres for 180 seconds.On (b)(6) 2025, the subject presented with gangrene of the right foot.The subject was hospitalized, and on (b)(6) 2025, amputation was performed.On (b)(6) 2025, the issue was considered resolved.The subject was discharged on (b)(6) 2025.

• 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: 24314542
• Report Number: 2124215-2026-07704
• Device Sequence Number: 4863304
• Product Code: ONU
• UDI-Device Identifier: 08714729975823
• UDI-Public: (01)08714729975823(17)240823(10)6830H22
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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 Expiration Date: 08/23/2024
• Device Model Number: H74939419401010
• Device Catalogue Number: H74939419401010
• Device Lot Number: 06830H22
• 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: 01/16/2026
• Initial Report FDA Received Date: 02/11/2026
• Date Device Manufactured: 08/24/2022
• 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; Hospitalization; Other
• Patient Sex: Female