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

Model Number	H74939419501590
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: age at time of event: the subject was 72 years old at the time of study enrollment.
Event or Problem Description
It was reported that vessel dissection occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2023 as a part of the clinical trial.The target lesion #001 was in the left distal superficial femoral artery extending up to left proximal popliteal artery with 5.5 mm proximal reference vessel diameter and 4 mm distal reference vessel diameter with lesion length 200 mm with 100 percent stenosis and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed using 3 mm x 120 mm coyote balloon.Treatment of target lesion was performed by dilation using 5 mm x 150 mm ranger drug coated balloon, study device.Following treatment, the final residual stenosis was noted to be 29 percent.The target lesion #002 was in the left distal popliteal artery, left tibial peroneal trunk and left posterior tibial artery with 5 mm proximal reference vessel diameter and 3 mm distal reference vessel diameter with lesion length 80 mm with 100% stenosis and was classified as tasc ii d lesion.Treatment of target lesion was performed by dilation using 4 mm x 200 mm ranger drug coated balloon, study device.Following treatment, the final residual stenosis was noted to be 29%.On (b)(6) 2023, during the treatment of target lesion #001, significant flow-limiting dissection was noted in the left mid popliteal artery due to 5 mm x 150 mm ranger drug-coated balloon.In response to the event, balloon dilation was performed using 5 mm balloon.Post treatment angiography demonstrated brisk flow through the left sfa, popliteal into the posterior tibial and peroneal arteries.On the same day, the event was considered to be resolved.On (b)(6) 2023, the subject was discharged from the hospital on aspirin.
Additional Manufacturer Narrative
A2: age at time of event: the subject was 72 years old at the time of study enrollment.
Event or Problem Description
It was reported that vessel dissection occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2023 as a part of the clinical trial.The target lesion #001 was in the left distal superficial femoral artery extending up to left proximal popliteal artery with 5.5 mm proximal reference vessel diameter and 4 mm distal reference vessel diameter with lesion length 200 mm with 100% stenosis and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed using 3 mm x 120 mm coyote balloon.Treatment of target lesion was performed by dilation using 5 mm x 150 mm ranger drug coated balloon, study device.Following treatment, the final residual stenosis was noted to be 29%.The target lesion #002 was in the left distal popliteal artery, left tibial peroneal trunk and left posterior tibial artery with 5 mm proximal reference vessel diameter and 3 mm distal reference vessel diameter with lesion length 80 mm with 100% stenosis and was classified as tasc ii d lesion.Treatment of target lesion was performed by dilation using 4 mm x 200 mm ranger drug coated balloon, study device.Following treatment, the final residual stenosis was noted to be 29%.On (b)(6) 2023, during the treatment of target lesion #001, significant flow-limiting dissection was noted in the left mid popliteal artery due to 5 mm x 150 mm ranger drug-coated balloon.In response to the event, balloon dilation was performed using 5 mm balloon.Post treatment angiography demonstrated brisk flow through the left sfa, popliteal into the posterior tibial and peroneal arteries.On the same day, the event was considered to be resolved.On (b)(6) 2023, the subject was discharged from the hospital on aspirin.It was further reported that the target lesion #001 was also in the left proximal popliteal artery and left mid popliteal artery.Pre-dilation was performed using 3 mm x 150 mm coyote balloon, not the 120 mm previously reported.Also, it was further indicated that the balloon used as treatment was a 5 mm x 150 mm ranger drug-coated balloon and final residual stenosis was noted to be 0% (not 29%).

• 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: 22065323
• Report Number: 2124215-2025-30436
• Device Sequence Number: 7638596
• Product Code: ONU
• UDI-Device Identifier: 08714729976035
• UDI-Public: (01)08714729976035(17)250302(10)2143H23
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 07/17/2025

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: 03/02/2025
• Device Model Number: H74939419501590
• Device Catalogue Number: H74939419501590
• Device Lot Number: 02143H23
• 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: 06/20/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 03/03/2023
• 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: 72 YR
• Patient Sex: Male
• Patient Race: White