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

Model Number	H74939419600810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study that a flow-limiting dissection occurred.The subject underwent treatment with ranger drug-coated balloons on (b)(6) 2023 as a part of a clinical trial.The target lesion was in the left external iliac artery, left common femoral artery, left distal superficial femoral artery (sfa) extending up to left proximal popliteal artery with 5.0 mm proximal reference vessel diameter and 4.8 mm distal reference vessel diameter with lesion length of 132 mm and 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study device, lithotripsy was performed with shockwave lithotripsy device and pre-dilation was performed using 2.5 mm x 150 mm coyote pta balloon.Treatment of target lesion was performed by dilation using study device of size 5 mm x 200 mm and 6 mm x 80 mm ranger drug-coated balloons.During the treatment of target lesion, dissection of grade e was noted in the left femoropopliteal junction.It is unknown which device caused the dissection.In response to the dissection, a 6.0 mm x 120 mm eluvia drug-eluting stent was placed in the left distal sfa and was post dilated using a sterling balloon.Post treatment, the final residual stenosis was noted to be 30%.On the same day, the complication of dissection was resolved.On (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.

• 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: 22439538
• Report Number: 2124215-2025-44777
• Device Sequence Number: 17291517
• Product Code: ONU
• UDI-Device Identifier: 08714729976127
• UDI-Public: (01)08714729976127(17)240814(10)6512H22
• Combination Product (Y/N): Y
• Initial Reporter State: DE
• 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
• Report Date (Section B): 07/08/2025

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: 08/14/2024
• Device Model Number: H74939419600810
• Device Catalogue Number: H74939419600810
• Device Lot Number: 06512H22
• 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: 06/10/2025
• Initial Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 08/15/2022
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Race: White