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

Model Number	H74939419502010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection occurred, requiring intervention.On (b)(6) 2024, the subject underwent treatment with the ranger drug coated balloons as a part of the clinical trial.The target lesion was in the left proximal superficial femoral artery (sfa), left mid sfa extending up to left distal sfa with 50 mm proximal reference vessel diameter and 40 mm distal reference vessel diameter with lesion length 250 mm with 90% stenosis and was classified as tasc ii c lesion.Treatment of target lesion was performed by dilation using 5 mm x 200 mm ranger drug coated balloon, study device.A dissection of grade b was noted in the left sfa due to the 5 mm x 200 mm ranger drug coated balloon.In response to the dissection, a 6 mm x 40 mm innova stent was placed.Following treatment, a 60 mm x 80 mm innova bare metal stent was also placed, and final residual stenosis was noted to be 30%.On the same day, the event was considered to be resolved, and the subject was discharged from the hospital.
Additional Manufacturer Narrative
A2 age at time of event: 81 years old at the time of study enrollment.Detailed product information was not provided to boston scientific.The lot number was not provided by the clinical study, thus unable to provide the complete unique identifier (udi) # and other product specific information.
Event or Problem Description
It was reported that a dissection occurred, requiring intervention.On (b)(6) 2024, the subject underwent treatment with the ranger drug coated balloons as a part of the clinical trial.The target lesion was in the left proximal superficial femoral artery (sfa), left mid sfa extending up to left distal sfa with 50 mm proximal reference vessel diameter and 40 mm distal reference vessel diameter with lesion length 250 mm with 90% stenosis and was classified as tasc ii c lesion.Treatment of target lesion was performed by dilation using 5 mm x 200 mm ranger drug coated balloon, study device.A dissection of grade b was noted in the left sfa due to the 5 mm x 200 mm ranger drug coated balloon.In response to the dissection, a 6 mm x 40 mm innova stent was placed.Following treatment, a 60 mm x 80 mm innova bare metal stent was also placed, and final residual stenosis was noted to be 30%.On the same day, the event was considered to be resolved, and the subject was discharged from the hospital.It was further reported that on (b)(6) 2024, during the treatment of target lesion, dissection of grade b with some flow limitation was noted.In response to the event, 6 mm x 40 mm innova stent was placed and was post dilated by balloon angioplasty.In addition, angiogram revealed recalcitrant stenosis with recoil proximally in the target lesion which was treated by placement of 6mm innova stent and was post dilated by balloon angioplasty.On the same day, the event was considered to be resolved, and the subject was discharged from the hospital on aspirin.
Additional Manufacturer Narrative
A2 age at time of event: 81 years old at the time of study enrollment.Detailed product information was not provided to boston scientific.The lot number was not provided by the clinical study, thus unable to provide the complete unique identifier (udi) # and other product specific information.

• 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: 22039234
• Report Number: 2124215-2025-30405
• Device Sequence Number: 8899587
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: (01)08714729976042
• 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): 07/16/2025

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 Model Number: H74939419502010
• Device Catalogue Number: H74939419502010
• 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
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/16/2025
• 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: 81 YR
• Patient Sex: Female
• Patient Race: White