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

Model Number	H74939419501510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 - age at time of event: 75 years old at the time of study enrollment.
Event or Problem Description
It was reported that restenosis occurred requiring additional intervention.On (b)(6) 2022, the subject underwent treatment with the ranger drug coated balloon as a part of the clinical trial.The first target lesion was in the right distal popliteal artery and right tibial peroneal trunk with 4.5 mm proximal reference vessel diameter and 4 mm distal reference vessel diameter with 60 mm lesion length with 99 % stenosis and was classified as tasc ii class c lesion.Prior to treatment of target lesion with the study device, atherectomy was performed using 1.5 mm non-boston scientific (bsc) atherectomy device, pre-dilation was performed using 3 mm x 40 mm coyote pta balloon.Treatment of target lesion was performed by dilation using 4 mm x 80 mm ranger drug coated balloon.Following treatment, the final residual stenosis was noted to be 30%.The second target lesion was in the right mid superficial femoral artery and right distal superficial femoral artery with 5.5 mm proximal reference vessel diameter and 5.5 mm distal reference vessel diameter with 120 mm lesion length with 70 % stenosis and was classified as tasc ii class b lesion.Prior to treatment of target lesion with the study device, atherectomy was performed using 1.5 mm non-bsc atherectomy device, pre-dilation was performed using 5 mm x 120 mm sterling pta balloon.Treatment of target lesion was performed by dilation using 5 mm x 150 mm ranger drug coated balloon.Following treatment, the final residual stenosis was noted to be 20%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, subject was noted with symptoms related to stenosis of right superficial femoral artery and popliteal artery.In response to the event, target lesion revascularization was performed.On the same day, the event was considered to be resolved.
Event or Problem Description
It was reported that restenosis occurred requiring additional intervention.On (b)(6) -2022, the subject underwent treatment with the ranger drug coated balloon as a part of the clinical trial.The first target lesion was in the right distal popliteal artery and right tibial peroneal trunk with 4.5 mm proximal reference vessel diameter and 4 mm distal reference vessel diameter with 60 mm lesion length with 99 % stenosis and was classified as tasc ii class c lesion.Prior to treatment of target lesion with the study device, atherectomy was performed using 1.5 mm non-boston scientific (bsc) atherectomy device, pre-dilation was performed using 3 mm x 40 mm coyote pta balloon.Treatment of target lesion was performed by dilation using 4 mm x 80 mm ranger drug coated balloon.Following treatment, the final residual stenosis was noted to be 30%.The second target lesion was in the right mid superficial femoral artery and right distal superficial femoral artery with 5.5 mm proximal reference vessel diameter and 5.5 mm distal reference vessel diameter with 120 mm lesion length with 70 % stenosis and was classified as tasc ii class b lesion.Prior to treatment of target lesion with the study device, atherectomy was performed using 1.5 mm non-bsc atherectomy device, pre-dilation was performed using 5 mm x 120 mm sterling pta balloon.Treatment of target lesion was performed by dilation using 5 mm x 150 mm ranger drug coated balloon.Following treatment, the final residual stenosis was noted to be 20%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, subject was noted with symptoms related to stenosis of right superficial femoral artery and popliteal artery.In response to the event, target lesion revascularization was performed.On the same day, the event was considered to be resolved.It was further reported that the second target lesion was in the right distal superficial femoral artery.On (b)(6) 2023, the subject visited the hospital with complaint of severe and worsening right calf claudication with decreased doppler signal in the right pedal arteries.Hence, subject was planned for right lower extremity angiogram with possible intervention on a later date.(b)(6) 2023 is considered as the onset date of the event.On (b)(6) 2023, subject visited the hospital for right lower extremity angiogram in the setting of ongoing severe calf claudication.Rutherford assessment revealed class iii claudication in the right calf.The subject was noted with atherosclerosis of right lower extremity with intermittent claudication.Physical examination revealed right pulses 1+ with biphasic signal in dorsalis pedis/posterior tibial artery, left pulses 2+ with triphasic signals.On the same day, bilateral lower extremity angiogram revealed: left lower extremity: eccentric calcified 35% stenosis was noted in common femoral artery.Right lower extremity (target limb): mild diffuse 25% calcified disease in common femoral artery and profunda femoral artery; eccentric 30% calcified stenosis in near ostial sfa; multisegmental 70-80% severely calcified nodular stenosis in mid to distal sfa; 90% calcified stenosis in distal popliteal artery; very distal chronic calcified occlusion was noted in anterior tibial artery with no visualization of dorsalis pedis artery; mid to distal chronic calcified occlusion in posterior tibial artery, peroneal artery terminating at the ankle and provided collateral reconstitution of plantar artery in the foot.On (b)(6) -2023, 329 days post index procedure,70-80% stenosis noted in right mid to distal superficial femoral artery and 90 % stenosis noted in right distal popliteal artery was treated by orbital atherectomy using 1.5 mm diamondback crown atherectomy device.Followed by balloon angioplasty using 5 mm x 200 mm sterling pta balloon in right distal sfa and 4 mm x 40 mm sterling pta balloon in right distal popliteal artery.Subsequently, drug coated balloon angioplasty was performed by using 6 mm x 200 mm ranger dcb in right distal sfa and 5 mm x 40 mm ranger dcb in right distal popliteal artery.Post treatment, 25% residual stenosis was noted from right mid to distal sfa and 20% residual stenosis was noted in right distal popliteal artery.Only right distal sfa was treated by drug coated balloon angioplasty with 20% residual stenosis.Further selective angiography of the right peroneal artery revealed significant collateral reconstitution of plantar arteries in right foot.On the same, the event was considered to be resolved, and the subject was discharged from the hospital on dual antiplatelet therapy.
Additional Manufacturer Narrative
A2 - age at time of event: 75 years old at the time of study enrollment b5.Describe event or problem: added information, based on additional information.
Additional Manufacturer Narrative
A2 - age at time of event: 75 years old at the time of study enrollment.A4 - weight: 71.7 kg.B5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that restenosis occurred requiring additional intervention.On (b)(6) 2022, the subject underwent treatment with the ranger drug coated balloon as a part of the clinical trial.The first target lesion was in the right distal popliteal artery and right tibial peroneal trunk with 4.5 mm proximal reference vessel diameter and 4 mm distal reference vessel diameter with 60 mm lesion length with 99 % stenosis and was classified as tasc ii class c lesion.Prior to treatment of target lesion with the study device, atherectomy was performed using 1.5 mm non-boston scientific (bsc) atherectomy device, pre-dilation was performed using 3 mm x 40 mm coyote pta balloon.Treatment of target lesion was performed by dilation using 4 mm x 80 mm ranger drug coated balloon.Following treatment, the final residual stenosis was noted to be 30%.The second target lesion was in the right mid superficial femoral artery and right distal superficial femoral artery with 5.5 mm proximal reference vessel diameter and 5.5 mm distal reference vessel diameter with 120 mm lesion length with 70 % stenosis and was classified as tasc ii class b lesion.Prior to treatment of target lesion with the study device, atherectomy was performed using 1.5 mm non-bsc atherectomy device, pre-dilation was performed using 5 mm x 120 mm sterling pta balloon.Treatment of target lesion was performed by dilation using 5 mm x 150 mm ranger drug coated balloon.Following treatment, the final residual stenosis was noted to be 20%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, subject was noted with symptoms related to stenosis of right superficial femoral artery and popliteal artery.In response to the event, target lesion revascularization was performed.On the same day, the event was considered to be resolved.It was further reported that the second target lesion was in the right distal superficial femoral artery.On un (b)(6) 2023, the subject visited the hospital with complaint of severe and worsening right calf claudication with decreased doppler signal in the right pedal arteries.Hence, subject was planned for right lower extremity angiogram with possible intervention on a later date.On 03-aug- 2023 is considered as the onset date of the event.On (b)(6) 2023, subject visited the hospital for right lower extremity angiogram in the setting of ongoing severe calf claudication.Rutherford assessment revealed class iii claudication in the right calf.The subject was noted with atherosclerosis of right lower extremity with intermittent claudication.Physical examination revealed right pulses 1+ with biphasic signal in dorsalis pedis/posterior tibial artery, left pulses 2+ with triphasic signals.On the same day, bilateral lower extremity angiogram revealed: left lower extremity: eccentric calcified 35% stenosis was noted in common femoral artery.Right lower extremity (target limb): mild diffuse 25% calcified disease in common femoral artery and profunda femoral artery; eccentric 30% calcified stenosis in near ostial sfa; multisegmental 70-80% severely calcified nodular stenosis in mid to distal sfa; 90% calcified stenosis in distal popliteal artery; very distal chronic calcified occlusion was noted in anterior tibial artery with no visualization of dorsalis pedis artery; mid to distal chronic calcified occlusion in posterior tibial artery, peroneal artery terminating at the ankle and provided collateral reconstitution of plantar artery in the foot.On (b)(6) 2023, 329 days post index procedure,70-80% stenosis noted in right mid to distal superficial femoral artery and 90 % stenosis noted in right distal popliteal artery was treated by orbital atherectomy using 1.5 mm diamondback crown atherectomy device.Followed by balloon angioplasty using 5 mm x 200 mm sterling pta balloon in right distal sfa and 4 mm x 40 mm sterling pta balloon in right distal popliteal artery.Subsequently, drug coated balloon angioplasty was performed by using 6 mm x 200 mm ranger dcb in right distal sfa and 5 mm x 40 mm ranger dcb in right distal popliteal artery.Post treatment, 25% residual stenosis was noted from right mid to distal sfa and 20% residual stenosis was noted in right distal popliteal artery.Only right distal sfa was treated by drug coated balloon angioplasty with 20% residual stenosis.Further selective angiography of the right peroneal artery revealed significant collateral reconstitution of plantar arteries in right foot.On the same, the event was considered to be resolved, and the subject was discharged from the hospital on dual antiplatelet therapy.It was further reported that the restenosis occurred on the right femoropopliteal 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23222229
• Report Number: 2124215-2025-68331
• Device Sequence Number: 9478598
• Product Code: ONU
• UDI-Device Identifier: 08714729976028
• UDI-Public: (01)08714729976028(17)240330(10)2882H22
• 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,Followup,Followup
• Report Date (Section B): 01/26/2026

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: 03/30/2024
• Device Model Number: H74939419501510
• Device Catalogue Number: H74939419501510
• Device Lot Number: 02882H22
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 10/10/2025; 12/31/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/06/2025; 01/26/2026
• Date Device Manufactured: 03/31/2022
• 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
• Patient Sex: Male
• Patient Race: Asian