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

Model Number	H74939419602010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 - age at time of event: 71 years old at the time of consent.A4 - weight: 164.4 lb.
Event or Problem Description
It was reported that revision of common femoral artery to popliteal artery bypass occurred.On (b)(6) 2024, two 6.0 x 150mm, 150cm ranger were selected for use as part of the clinical study.On (b)(6) 2025, it was noted that a revision of common femoral artery to popliteal artery bypass occurred which resulted in prolonged hospitalization.The patient was discharged from the hospital on (b)(6) 2025.
Event or Problem Description
It was reported that revision of common femoral artery to popliteal artery bypass occurred.On (b)(6) 2024, two 6.0 x 150mm, 150cm ranger were selected for use as part of the clinical study.On (b)(6) 2025, it was noted that a revision of common femoral artery to popliteal artery bypass occurred which resulted in prolonged hospitalization.The patient was discharged from the hospital on (b)(6) 2025.It was further reported that right superficial femoral artery occlusive disease with rest pain occurred.
Additional Manufacturer Narrative
A2 - age at time of event: 71 years old at the time of consent.A4 - weight: 164.4 lb.B5.Describe event or problem: added information, based on additional information.
Additional Manufacturer Narrative
A2 - age at time of event: 71 years old at the time of consent a4 - weight: 164.4 lb b5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that revision of common femoral artery to popliteal artery bypass occurred.On (b)(6) 2024, two 6.0 x 150mm, 150cm ranger were selected for use as part of the clinical study.On 16-oct-2025, it was noted that a revision of common femoral artery to popliteal artery bypass occurred which resulted in prolonged hospitalization.The patient was discharged from the hospital on (b)(6) 2025.It was further reported that right superficial femoral artery occlusive disease with rest pain occurred.It was further reported that the location of the intervention was on the right proximal superficial femoral artery.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23844155
• Report Number: 2124215-2025-91857
• Device Sequence Number: 13154721
• Product Code: ONU
• UDI-Device Identifier: 08714729976202
• UDI-Public: (01)08714729976202(17)251124(10)12044H23
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 04/23/2026

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: 11/24/2025
• Device Model Number: H74939419602010
• Device Catalogue Number: H74939419602010
• Device Lot Number: 12044H23
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 02/10/2026; 04/01/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/09/2026; 04/23/2026
• Date Device Manufactured: 11/25/2023
• 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: Male