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	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel dissection occurred.The subject underwent treatment with the eluvia drug eluting stent and ranger drug coated balloon on (b)(6) 2023 as a part of the clinical trial.The target lesion #001 was in the left proximal superficial femoral artery, left mid superficial femoral artery extending up to left distal superficial femoral artery with 3.9 mm proximal reference vessel diameter and 4.5 mm distal reference vessel diameter with lesion length 172 mm with 100 % stenosis and was classified as tasc ii c lesion.Prior to the treatment of target lesion with study devices, pre-dilation was performed using 4 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by using study devices, 6 mm x 60 mm eluvia drug eluting stent and 5 mm x 200 mm ranger drug coated balloon.Following treatment, post-dilation was performed using 5 mm x 60 mm sterling pta balloon.Following treatment, the final residual stenosis was noted to be 0%.On the same day of index procedure, dissection of grade a was noted due to 0.018 x 135 cm rubicon catheter.In response to the complication, balloon dilation and bailout stenting was performed.Post treatment, the final residual stenosis was noted to be 0% and the complication of dissection was resolved and, the subject was discharged from hospital.It was further reported that baseline core-lab angiography findings dated (b)(6) 2023 revealed: grade 0 thrombus, grade 0 timi flow, with 100% baseline stenosis, tasc ii type of d and absence of aneurysm.In addition, post drug coated balloon, study device analysis revealed grade 0 thrombus, absence of aneurysm, timi flow of grade 3 and dissection of grade c with 54 percent in-segment post stenosis.Post drug eluting stent, study device analysis revealed grade 0 thrombus with timi flow of grade 3, and absence of aneurysm or dissection.
Additional Manufacturer Narrative
A2: age at time of event: 65 years old at the time of study enrollment.
Additional Manufacturer Narrative
A2: age at time of event: 65 years old at the time of study enrollment.E1 - initial reporter email: added.
Event or Problem Description
It was reported that vessel dissection occurred.The subject underwent treatment with the eluvia drug eluting stent and ranger drug coated balloon on (b)(6) 2023 as a part of the clinical trial.The target lesion #001 was in the left proximal superficial femoral artery, left mid superficial femoral artery extending up to left distal superficial femoral artery with 3.9 mm proximal reference vessel diameter and 4.5 mm distal reference vessel diameter with lesion length 172 mm with 100 % stenosis and was classified as tasc ii c lesion.Prior to the treatment of target lesion with study devices, pre-dilation was performed using 4 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by using study devices, 6 mm x 60 mm eluvia drug eluting stent and 5 mm x 200 mm ranger drug coated balloon.Following treatment, post-dilation was performed using 5 mm x 60 mm sterling pta balloon.Following treatment, the final residual stenosis was noted to be 0%.On the same day of index procedure, dissection of grade a was noted due to 0.018 x 135 cm rubicon catheter.In response to the complication, balloon dilation and bailout stenting was performed.Post treatment, the final residual stenosis was noted to be 0% and the complication of dissection was resolved and, the subject was discharged from hospital.It was further reported that baseline core-lab angiography findings dated 13-dec-2023 revealed: grade 0 thrombus, grade 0 timi flow, with 100% baseline stenosis, tasc ii type of d and absence of aneurysm.In addition, post drug coated ballon, study device analysis revealed grade 0 thrombus, absence of aneurysm, timi flow of grade 3 and dissection of grade c with 54% in-segment post stenosis.Post drug eluting stent, study device analysis revealed grade 0 thrombus with timi flow of grade 3, and absence of aneurysm or dissection.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23647194
• Report Number: 2124215-2025-85634
• Device Sequence Number: 18632249
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: (01)08714729976042(17)250702(10)6067H23
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 03/30/2026

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: 07/02/2025
• Device Model Number: H74939419502010
• Device Catalogue Number: H74939419502010
• Device Lot Number: 06067H23
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 07/03/2023
• 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: 65 YR
• Patient Sex: Female
• Patient Race: Black Or African American