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

Model Number	H74939419402010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis and pain occurred.On (b)(6) 2024, the subject underwent treatment with the ranger drug coated balloons as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial femoral artery (sfa), right mid superficial femoral artery, right distal superficial femoral artery extending up to right proximal popliteal artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length of 390 mm and 100% stenosis and was classified as tasc ii d lesion.Treatment of target lesion was performed by dilation using study devices, 6 mm x 200 mm and 4 mm x 200 mm ranger drug coated balloons.Following treatment, 6 mm non-boston scientific (bsc) stent was placed from right proximal sfa extending to proximal popliteal artery followed by balloon tailoring yielding completion and the final residual stenosis was noted to be 40%.On the same day, the subject was discharged from hospital on clopidogrel.On (b)(6) 2025, subject visited the emergency department with the complaints of worsened right leg claudication with short walking distance and occasional rest pain.Of note, on outpatient duplex of right lower extremity revealed occluded superficial femoral artery, patent femoral to popliteal artery graft with elevated peak systolic velocity in proximal anastomosis, hemodynamically significant stenosis in popliteal artery, pre-occlusive peroneal artery and patent posterior tibial artery.On the same day, the subject was hospitalized for the right lower extremity angiogram with intervention due to high risk of femoral to popliteal artery graft occlusion.On (b)(6) 2025, right lower extremity angiogram revealed patent profunda femoris artery, patent right femoral to above knee popliteal artery bypass graft with 80% stenosis in the origin, 80% in-stent stenosis in p2 segment of popliteal artery, 90% stenosis in tibial peroneal artery, 70% stenosis in anterior tibial artery and occlude posterior tibial artery.On the same day, 299 days post index procedure, 80% stenosis noted in the right femoral to above knee popliteal artery was treated by atherectomy followed by balloon angioplasty using 4 mm x 15 mm wolverine cutting balloon followed by 5 mm x 40 mm balloon with final residual stenosis of 20%.In addition, 80% in-stent restenosis noted in right mid popliteal artery was treated using 5 mm x 40 mm ranger drug coated balloon.Stenosis noted in the right tibial peroneal trunk and peroneal artery was treated by balloon angioplasty using 3 mm x 40 mm non-bsc balloon with residual stenosis of less than 30%.Followed by 70% stenosis noted in right anterior tibial artery was treated by balloon angioplasty using 3 mm x 40 mm and 3.5 mm x 40 mm balloons followed by 4 mm x 40 mm ranger drug coated balloon with residual stenosis of 30%.Of note, non-target lesions were treated during revascularization.On the same day, the event was considered to be resolved.On (b)(6) 2025, triphasic right dp doppler signals and biphasic pt pulses were noted.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.
Event or Problem Description
It was reported that restenosis and pain occurred.On (b)(6) 2024, the subject underwent treatment with the ranger drug coated balloons as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial femoral artery (sfa), right mid superficial femoral artery, right distal superficial femoral artery extending up to right proximal popliteal artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length of 390 mm and 100% stenosis and was classified as tasc ii d lesion.Treatment of target lesion was performed by dilation using study devices, 6 mm x 200 mm and 4 mm x 200 mm ranger drug coated balloons.Following treatment, 6 mm non-boston scientific (bsc) stent was placed from right proximal sfa extending to proximal popliteal artery followed by balloon tailoring yielding completion and the final residual stenosis was noted to be 40%.On the same day, the subject was discharged from hospital on clopidogrel.On (b)(6) 2025, subject visited the emergency department with the complaints of worsened right leg claudication with short walking distance and occasional rest pain.Of note, on outpatient duplex of right lower extremity revealed occluded superficial femoral artery, patent femoral to popliteal artery graft with elevated peak systolic velocity in proximal anastomosis, hemodynamically significant stenosis in popliteal artery, pre-occlusive peroneal artery and patent posterior tibial artery.On the same day, the subject was hospitalized for the right lower extremity angiogram with intervention due to high risk of femoral to popliteal artery graft occlusion.On (b)(6) 2025, right lower extremity angiogram revealed patent profunda femoris artery, patent right femoral to above knee popliteal artery bypass graft with 80% stenosis in the origin, 80% in-stent stenosis in p2 segment of popliteal artery, 90% stenosis in tibial peroneal artery, 70% stenosis in anterior tibial artery and occlude posterior tibial artery.On the same day, 299 days post index procedure, 80% stenosis noted in the right femoral to above knee popliteal artery was treated by atherectomy followed by balloon angioplasty using 4 mm x 15 mm wolverine cutting balloon followed by 5 mm x 40 mm balloon with final residual stenosis of 20%.In addition, 80% in-stent restenosis noted in right mid popliteal artery was treated using 5 mm x 40 mm ranger drug coated balloon.Stenosis noted in the right tibial peroneal trunk and peroneal artery was treated by balloon angioplasty using 3 mm x 40 mm non-bsc balloon with residual stenosis of less than 30%.Followed by 70% stenosis noted in right anterior tibial artery was treated by balloon angioplasty using 3 mm x 40 mm and 3.5 mm x 40 mm balloons followed by 4 mm x 40 mm ranger drug coated balloon with residual stenosis of 30%.Of note, non-target lesions were treated during revascularization.On the same day, the event was considered to be resolved.On (b)(6) 2025, triphasic right dp doppler signals and biphasic pt pulses were noted.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.
Additional Manufacturer Narrative
H6: patient codes: updated.H6: impact codes: updated.

• 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: 23352448
• Report Number: 2124215-2025-74850
• Device Sequence Number: 8727527
• Product Code: ONU
• UDI-Device Identifier: 08714729975885
• UDI-Public: (01)08714729975885(17)260205(10)1455H24
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 02/05/2026
• Device Model Number: H74939419402010
• Device Catalogue Number: H74939419402010
• Device Lot Number: 01455H24
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/01/2025
• Date Device Manufactured: 02/06/2024
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic