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	12/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dissection occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2024 as a part of the clinical trial.The target lesion was in left proximal superficial femoral artery, left mid superficial femoral artery, and left distal superficial femoral artery, with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with 250 mm lesion length and 99% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study devices, atherectomy was performed using a non-boston scientific (bsc) atherectomy device.Treatment of target lesion was performed by dilation using 5 mm x 200 mm ranger drug-coated balloon and placement of 6 mm x 120 mm eluvia drug eluting stent, study devices.Following, atherectomy was performed using non-bsc device and post-dilation was performed using 6 mm x 120 mm armada pta balloon.Post procedure, the final residual stenosis was noted to be 20%.On (b)(6) 2024, on the same day of index procedure, post usage of 5 mm x 200 mm ranger drug coated balloon study device, angiography revealed severe flow limiting dissection of grade b in left proximal superficial femoral artery.Subsequently, an attempt was made to shave out the dissection flap and treat with prolonged repeat angioplasty using 5 mm x 200 mm ranger dcb, however, due to flow limiting nature of dissection, 6 x 120 mm eluvia drug eluting stent was placed followed by dilation using 6 mm x 120 mm non-bsc pta balloon.Post treatment, the final residual stenosis was noted to be less than 20% with brisk flow to the ankle with three vessel runoffs.On the same day, the event of dissection was resolved, and the subject was discharged from hospital on clopidogrel.
Event or Problem Description
It was reported that dissection occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2024 as a part of the clinical trial.The target lesion was in left proximal superficial femoral artery, left mid superficial femoral artery, and left distal superficial femoral artery, with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with 250 mm lesion length and 99% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study devices, atherectomy was performed using a non-boston scientific (bsc) atherectomy device.Treatment of target lesion was performed by dilation using 5 mm x 200 mm ranger drug-coated balloon and placement of 6 mm x 120 mm eluvia drug eluting stent, study devices.Following, atherectomy was performed using non-bsc device and post-dilation was performed using 6 mm x 120 mm armada pta balloon.Post procedure, the final residual stenosis was noted to be 20%.On (b)(6) 2024, on the same day of index procedure, post usage of 5 mm x 200 mm ranger drug coated balloon study device, angiography revealed severe flow limiting dissection of grade b in left proximal superficial femoral artery.Subsequently, an attempt was made to shave out the dissection flap and treat with prolonged repeat angioplasty using 5 mm x 200 mm ranger dcb, however, due to flow limiting nature of dissection, 6 x 120 mm eluvia drug eluting stent was placed followed by dilation using 6 mm x 120 mm non-bsc pta balloon.Post treatment, the final residual stenosis was noted to be less than 20% with brisk flow to the ankle with three vessel runoffs.On the same day, the event of dissection was resolved, and the subject was discharged from hospital on clopidogrel.It was further reported that on (b)(6) 2024, during the treatment of target lesion, dissection of grade c was noted in the left proximal superficial femoral artery due to 5 mm x 200 mm ranger drug coated balloon.

• 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: 21378512
• Report Number: 2124215-2025-07644
• Device Sequence Number: 3759209
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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): 07/29/2025

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: 01/11/2026
• Device Model Number: H74939419502010
• Device Catalogue Number: H74939419502010
• Device Lot Number: 13019H23
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 07/29/2025
• Date Device Manufactured: 01/12/2024
• 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: 71 YR
• Patient Sex: Female