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

Model Number	H74939419400810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vasoconstriction (2126); Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 age at time of event: 63 years old at the time of study enrollment.
Event or Problem Description
It was reported that dissection occurred, requiring intervention.On (b)(6) 2024, the subject underwent treatment with the ranger drug coated balloon as part of clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery, right proximal popliteal artery, and right distal popliteal artery with 4 mm proximal reference vessel diameter and 300 mm distal reference vessel diameter with lesion length of 300 mm and 70% stenosis and was classified as tasc ii b lesion.Treatment of target lesion was performed by dilation using 4 mm x 300 mm ranger drug-coated balloon study device.Post target lesion treatment was performed by placement of 5 mm x 80 mm, 5 mm x 200 mm, and 5 mm x 40 mm innova bare metal stents, and the final residual stenosis was noted to be 10%.On the same day, during the treatment of target lesion, dissection of grade d was noted in the right superficial femoral artery due to 4 mm x 300 mm ranger drug-coated balloon study device.In response to the event, bailout stent was placed.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event was considered to be resolved and the subject was discharged from hospital on dual antiplatelet therapy.
Event or Problem Description
It was reported that dissection occurred, requiring intervention.On (b)(6) 2024, the subject underwent treatment with the ranger drug coated balloon as part of clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery, right proximal popliteal artery, and right distal popliteal artery with 4 mm proximal reference vessel diameter and 300 mm distal reference vessel diameter with lesion length of 300 mm and 70% stenosis and was classified as tasc ii b lesion.Treatment of target lesion was performed by dilation using 4 mm x 300 mm ranger drug-coated balloon study device.Post target lesion treatment was performed by placement of 5 mm x 80 mm, 5 mm x 200 mm, and 5 mm x 40 mm innova bare metal stents, and the final residual stenosis was noted to be 10%.On the same day, during the treatment of target lesion, dissection of grade d was noted in the right superficial femoral artery due to 4 mm x 300 mm ranger drug-coated balloon study device.In response to the event, bailout stent was placed.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.It was further reported that the target lesion had a 4 mm distal reference vessel diameter, not 300 mm as previously reported.Moreover, angiography revealed significant recoil in the target lesion.In response to the dissection and recoil, 5 mm x 80 mm, 5 mm x 200 mm, and 5 mm x 40 mm innova bare metal stents were placed from the level of hunter's canal to origin of right superficial femoral artery.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event dissection was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.
Additional Manufacturer Narrative
A2 age at time of event: 63 years old at the time of study enrollment.
Event or Problem Description
It was reported that dissection occurred, requiring intervention.On (b)(6) 2024, the subject underwent treatment with the ranger drug coated balloon as part of clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery, right proximal popliteal artery, and right distal popliteal artery with 4 mm proximal reference vessel diameter and 300 mm distal reference vessel diameter with lesion length of 300 mm and 70% stenosis and was classified as tasc ii b lesion.Treatment of target lesion was performed by dilation using 4 mm x 300 mm ranger drug-coated balloon study device.Post target lesion treatment was performed by placement of 5 mm x 80 mm, 5 mm x 200 mm, and 5 mm x 40 mm innova bare metal stents, and the final residual stenosis was noted to be 10%.On the same day, during the treatment of target lesion, dissection of grade d was noted in the right superficial femoral artery due to 4 mm x 300 mm ranger drug-coated balloon study device.In response to the event, bailout stent was placed.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.It was further reported that the target lesion had a 4 mm distal reference vessel diameter, not 300 mm as previously reported.Moreover, angiography revealed significant recoil in the target lesion.In response to the dissection and recoil, 5 mm x 80 mm, 5 mm x 200 mm, and 5 mm x 40 mm innova bare metal stents were placed from the level of hunter's canal to origin of right superficial femoral artery.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event dissection was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.It was further clarified that on (b)(6) 2024, the recoil in the right superficial femoral artery was due to 4 mm x 300 mm ranger drug-coated balloon.
Additional Manufacturer Narrative
A2 age at time of event: 63 years old at the time of study enrollment.
Additional Manufacturer Narrative
Correction to field h6: patient codes.A2 age at time of event: 63 years old at the time of study enrollment.
Event or Problem Description
It was reported that dissection occurred, requiring intervention.On (b)(6) 2024, the subject underwent treatment with the ranger drug coated balloon as part of clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery, right proximal popliteal artery, and right distal popliteal artery with 4 mm proximal reference vessel diameter and 300 mm distal reference vessel diameter with lesion length of 300 mm and 70% stenosis and was classified as tasc ii b lesion.Treatment of target lesion was performed by dilation using 4 mm x 300 mm ranger drug-coated balloon study device.Post target lesion treatment was performed by placement of 5 mm x 80 mm, 5 mm x 200 mm, and 5 mm x 40 mm innova bare metal stents, and the final residual stenosis was noted to be 10%.On the same day, during the treatment of target lesion, dissection of grade d was noted in the right superficial femoral artery due to 4 mm x 300 mm ranger drug-coated balloon study device.In response to the event, bailout stent was placed.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.It was further reported that the target lesion had a 4 mm distal reference vessel diameter, not 300 mm as previously reported.Moreover, angiography revealed significant recoil in the target lesion.In response to the dissection and recoil, 5 mm x 80 mm, 5 mm x 200 mm, and 5 mm x 40 mm innova bare metal stents were placed from the level of hunter's canal to origin of right superficial femoral artery.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event dissection was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.It was further clarified that on (b)(6) 2024, the recoil in the right superficial femoral artery was due to 4 mm x 300 mm ranger drug-coated balloon.
Event or Problem Description
It was reported that dissection occurred, requiring intervention.On (b)(6) 2024, the subject underwent treatment with the ranger drug coated balloon as part of clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery, right proximal popliteal artery, and right distal popliteal artery with 4 mm proximal reference vessel diameter and 300 mm distal reference vessel diameter with lesion length of 300 mm and 70% stenosis and was classified as tasc ii b lesion.Treatment of target lesion was performed by dilation using 4 mm x 300 mm ranger drug-coated balloon study device.Post target lesion treatment was performed by placement of 5 mm x 80 mm, 5 mm x 200 mm, and 5 mm x 40 mm innova bare metal stents, and the final residual stenosis was noted to be 10%.On the same day, during the treatment of target lesion, dissection of grade d was noted in the right superficial femoral artery due to 4 mm x 300 mm ranger drug-coated balloon study device.In response to the event, bailout stent was placed.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.It was further reported that the target lesion had a 4 mm distal reference vessel diameter, not 300 mm as previously reported.Moreover, angiography revealed significant recoil in the target lesion.In response to the dissection and recoil, 5 mm x 80 mm, 5 mm x 200 mm, and 5 mm x 40 mm innova bare metal stents were placed from the level of hunter's canal to origin of right superficial femoral artery.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event dissection was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.It was further clarified that on (b)(6) 2024, the recoil in the right superficial femoral artery was due to 4 mm x 300 mm ranger drug-coated balloon.It was further reported that the bailout stent was placed was a 5 mm innova stent.The number of inflation is 1 and the maximum inflation pressure was 10 atmospheres for the duration of 150 seconds.On (b)(6) 2024, the recoil in the right superficial femoral artery was resolved.
Additional Manufacturer Narrative
A4: weight: updated a2 age at time of event: 63 years old at the time of study enrollment.

• 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: 22057097
• Report Number: 2124215-2025-30423
• Device Sequence Number: 8347943
• Product Code: ONU
• UDI-Device Identifier: 08714729975809
• UDI-Public: (01)08714729975809(17)250309(10)2351H23
• Combination Product (Y/N): Y
• 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,Followup,Followup
• Report Date (Section B): 12/22/2025

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: 03/09/2025
• Device Model Number: H74939419400810
• Device Catalogue Number: H74939419400810
• Device Lot Number: 02351H23
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 07/22/2025; 10/16/2025; 12/06/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/18/2025; 08/19/2025; 10/16/2025; 12/22/2025
• Date Device Manufactured: 03/10/2023
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: Black Or African American