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

Model Number	H74939419600610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 age of the patient at the time of enrollment - 66 years old.
Event or Problem Description
It was reported that the subject experienced left lower extremity gangrene, requiring intervention and amputation.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2024 as a part of a clinical trial.The target lesion #001 was in the left proximal superficial femoral artery (sfa) with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 20 mm lesion length with 90% stenosis and was classified as transatlantic inter-society consensus (tasc) ii class a lesion.Prior to the treatment of target lesion, lithotripsy was performed using 6 mm x 60 mm shockwave medical device and balloon dilation was performed using 6 mm x 100 mm non-boston scientific drug coated balloon.Treatment of target lesion was performed by dilation using 6 mm x 60 mm ranger drug coated balloon, study device.Post procedure, the final residual stenosis was noted to be 20%.On the same day, the subject was discharged from the hospital on clopidogrel.On (b)(6) 2024, the subject underwent left common femoral artery to posterior tibial artery bypass for gangrenous left toes with popliteal and tibial disease.On (b)(6) 2024, the subject underwent left foot trans metatarsal amputation.
Additional Manufacturer Narrative
A2 age of the patient at the time of enrollment - 66 years old.B2: added required intervention selection updated b5 based on the additional information received.
Event or Problem Description
It was reported that the subject experienced left lower extremity gangrene, requiring intervention and amputation.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2024 as a part of a clinical trial.The target lesion #001 was in the left proximal superficial femoral artery (sfa) with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 20 mm lesion length with 90% stenosis and was classified as transatlantic inter-society consensus (tasc) ii class a lesion.Prior to the treatment of target lesion, lithotripsy was performed using 6 mm x 60 mm shockwave medical device and balloon dilation was performed using 6 mm x 100 mm non-boston scientific drug coated balloon.Treatment of target lesion was performed by dilation using 6 mm x 60 mm ranger drug coated balloon, study device.Post procedure, the final residual stenosis was noted to be 20%.On the same day, the subject was discharged from the hospital on clopidogrel.On (b)(6) 2024, the subject underwent left common femoral artery to posterior tibial artery bypass for gangrenous left toes with popliteal and tibial disease.On (b)(6) 2024, the subject underwent left foot trans metatarsal amputation.It was further reported that balloon dilation was performed using 5 mm x 60 mm non-boston scientific pta balloon and 2.5 mm x 150 mm non-boston scientific pta balloon.

• 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: 22056043
• Report Number: 2124215-2025-32401
• Device Sequence Number: 4250992
• Product Code: ONU
• UDI-Device Identifier: 08714729976103
• UDI-Public: (01)08714729976103(17)250808(10)7300H23
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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
• Report Date (Section B): 08/14/2025

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: 08/08/2025
• Device Model Number: H74939419600610
• Device Catalogue Number: H74939419600610
• Device Lot Number: 07300H23
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 08/14/2025
• Date Device Manufactured: 08/09/2023
• 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: Other; Required Intervention
• Patient Sex: Male
• Patient Race: Black Or African American