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 Code	Vascular Dissection (3160)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) study: it was reported that vessel dissection occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal sfa, left mid sfa extending to left distal sfa with 6.5 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length of 300 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment, pta balloon was performed with sterling 5.0 mm x 200 mm and sterling 6.0 mm x 220 mm pta balloon.The treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon of 6.0 mm x 200 mm and 6 mm x 150 mm followed by placement of study device, eluvia drug eluting stent 7 mm x 120 mm.Following post dilatation was performed with 6.0 mm x 100 mm sterling pta balloon and the final residual stenosis was noted to be 9%.On (b)(6) 2022, the subject was discharged from the hospital.On (b)(6) 2022, on the same day of index procedure, after treatment of the target lesion, dissection of grade c was noted in the target lesion.Site confirmed the dissection occurred due to ranger drug coated balloon 6.0 mm x 150 mm.In response to the dissection noted, a bailout stent was placed.Post treatment, the final stenosis was noted to be 9%.
Additional Manufacturer Narrative
Patient identifier: (b)(6).Age at time of enrollment- (b)(6) at time of enrollment.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).A2: age at time of enrollment- 66 years at time of enrollment.
Event or Problem Description
Elegance study.It was reported that vessel dissection occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery (sfa), left mid sfa extending to left distal sfa with 6.5 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length of 300 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment, pta balloon was performed with sterling 5.0 mm x 200 mm and sterling 6.0 mm x 220 mm pta balloon.The treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon of 6.0 mm x 200 mm and 6 mm x 150 mm followed by placement of study device, eluvia drug eluting stent 7 mm x 120 mm.Following post dilatation was performed with 6.0 mm x 100 mm sterling pta balloon and the final residual stenosis was noted to be 9%.On (b)(6)2022, the subject was discharged from the hospital.On (b)(6) 2022, on the same day of index procedure, after treatment of the target lesion, dissection of grade c was noted in the target lesion.Site confirmed the dissection occurred due to ranger drug coated balloon 6.0 mm x 150 mm.In response to the dissection noted, a bailout stent was placed.Post treatment, the final stenosis was noted to be 9%.It was further reported that the device which caused the dissection is unknown.In response to dissection, 7 mmx 120 mm eluvia drug eluting stent was placed.The final residual stenosis after the index procedure was 0%.On the same day, the complication of dissection was resolved.On (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.

• 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): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 14366049
• Report Number: 2134265-2022-05213
• Device Sequence Number: 13954942
• Product Code: ONU
• UDI-Device Identifier: 08714729976189
• UDI-Public: 08714729976189
• 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
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

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: 12/21/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00112H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 04/02/2024; 09/01/2026
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 04/29/2024; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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 Sex: Male
• Patient Race: White