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

Model Number	1973-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Vascular Dissection (3160); Embolism/Embolus (4438); Restenosis (4576)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) clinical study.It was reported that embolism occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion #001 was in the right common femoral artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 7 mm with lesion length of 130 mm and 90% stenosis and was classified as transatlantic intersociety consensus (tasc) ii a lesion.Prior to target lesion treatment, lithotripsy was performed with shockwave intravascular lithotripsy (ivl) device, 6 x 60 mm and treatment of target lesion was performed by dilatation with study device (ranger drug coated balloon of 7.0 mm x 150 mm) prior to lithotripsy, atherectomy was performed with a nob-boston scientific coronary orbital atherectomy system.On (b)(6) 2021, after the completion of the index procedure in the right common femoral artery (target lesion), the right foot was noted to be pale and cold.The subject had a complaint of pain in the right leg.Subsequently, angiogram was performed which demonstrated no flow to the foot which was unchanged from prior angiogram and embolism was noted in the foot which occluded the small peroneal artery.In response to the embolism that occluded the peroneal artery, balloon angioplasty was performed using a coyote 2.0 mm x 80 mm balloon and flow was restored into the more distal peroneal artery with a trickle of flow into the foot.As the flow was slow post dilatation, it was decided to revascularize the chronically occluded anterior tibial artery.The occlusion in the right anterior tibial artery was pre-dilated with a 2.0 mm x 220 mm coyote balloon followed by a 2.5 mm x 220 mm and subsequently stented proximally with two sequential 3.0 mm x 38 mm promus elite stents.Following the procedure, the final residual stenosis was 0% with good runoff and there was good blush on the toes and a bounding pulse in the foot.On (b)(6) 2021, the subject was discharged with dual antiplatelet therapy.
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
(b)(6) clinical study.It was reported that embolism occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion #001 was in the right common femoral artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 7 mm with lesion length of 130 mm and 90% stenosis and was classified as transatlantic intersociety consensus (tasc) ii a lesion.Prior to target lesion treatment, lithotripsy was performed with shockwave intravascular lithotripsy (ivl) device, 6 x 60 mm and treatment of target lesion was performed by dilatation with study device (ranger drug coated balloon of 7.0 mm x 150 mm) prior to lithotripsy, atherectomy was performed with a nob-boston scientific coronary orbital atherectomy system.On (b)(6) 2021, after the completion of the index procedure in the right common femoral artery (target lesion), the right foot was noted to be pale and cold.The subject had a complaint of pain in the right leg.Subsequently, angiogram was performed which demonstrated no flow to the foot which was unchanged from prior angiogram and embolism was noted in the foot which occluded the small peroneal artery.In response to the embolism that occluded the peroneal artery, balloon angioplasty was performed using a coyote 2.0 mm x 80 mm balloon and flow was restored into the more distal peroneal artery with a trickle of flow into the foot.As the flow was slow post dilatation, it was decided to revascularize the chronically occluded anterior tibial artery.The occlusion in the right anterior tibial artery was pre-dilated with a 2.0 mm x 220 mm coyote balloon followed by a 2.5 mm x 220 mm and subsequently stented proximally with two sequential 3.0 mm x 38 mm promus elite stents.Following the procedure, the final residual stenosis was 0% with good runoff and there was good blush on the toes and a bounding pulse in the foot.On (b)(6) 2021, the subject was discharged with dual antiplatelet therapy.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).B5: describe event or problem: additional information.H6: patient codes: added restenosis and vascular dissection codes.
Event or Problem Description
Elegance clinical study.It was reported that embolism occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion #001 was in the right common femoral artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 7 mm with lesion length of 130 mm and 90% stenosis and was classified as transatlantic intersociety consensus (tasc) ii a lesion.Prior to target lesion treatment, lithotripsy was performed with shockwave intravascular lithotripsy (ivl) device, 6 x 60 mm and treatment of target lesion was performed by dilatation with study device (ranger drug coated balloon of 7.0 mm x 150 mm) prior to lithotripsy, atherectomy was performed with a nob-boston scientific coronary orbital atherectomy system.On (b)(6) 2021, after the completion of the index procedure in the right common femoral artery (target lesion), the right foot was noted to be pale and cold.The subject had a complaint of pain in the right leg.Subsequently, angiogram was performed which demonstrated no flow to the foot which was unchanged from prior angiogram and embolism was noted in the foot which occluded the small peroneal artery.In response to the embolism that occluded the peroneal artery, balloon angioplasty was performed using a coyote 2.0 mm x 80 mm balloon and flow was restored into the more distal peroneal artery with a trickle of flow into the foot.As the flow was slow post dilatation, it was decided to revascularize the chronically occluded anterior tibial artery.The occlusion in the right anterior tibial artery was pre-dilated with a 2.0 mm x 220 mm coyote balloon followed by a 2.5 mm x 220 mm and subsequently stented proximally with two sequential 3.0 mm x 38 mm promus elite stents.Following the procedure, the final residual stenosis was 0% with good runoff and there was good blush on the toes and a bounding pulse in the foot.On (b)(6) 2021, the subject was discharged with dual antiplatelet therapy.It was further reported that baseline core-lab angiography findings for target lesion 001 dated (b)(6) 2021 revealed: severe calcification, grade 0 thrombus and timi flow 3, absence of aneurysm, with 73.21% baseline stenosis and with tasc ii type of b in right common femoral artery, bifurcation of common femoral artery and proximal superficial femoral artery.In addition, post study device analysis for drug coated balloon revealed grade 0 thrombus, absence of aneurysm, timi flow of grade 3 and in segment post stenosis was noted to be 36% with dissection grade c.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• 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): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 13593785
• Report Number: 2134265-2022-02101
• Device Sequence Number: 3769875
• Product Code: ONU
• UDI-Device Identifier: 08714729976349
• UDI-Public: (01)08714729976349(17)221030(10)27528495
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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): 12/12/2025

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: 10/30/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 0027528495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Race: White