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	09/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).A2: age at time of event: 65 years old at the time of study enrollment.
Event or Problem Description
Elegance clinical trial.It was reported that vessel dissection occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion #001 was in the right distal superficial femoral artery extending up to right proximal popliteal artery with 6 mm proximal reference vessel diameter and 5.5 mm distal reference vessel diameter with lesion length 200 mm with 100% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed using 5 mm x 100 mm sterling over the wire balloon pta balloon.Treatment of target lesion was performed by dilation using study device, 6 mm x 150 mm ranger drug-coated balloon.Following post-treatment was performed by placement of 6 mm x 150 mm non-boston scientific (bsc) peripheral stent system bare metal stent and, the final residual stenosis was noted to be 29%.The right distal superficial femoral artery to mid popliteal artery were treated by 6 mm x 150 mm ranger dcb (study device).Hence, it was confirmed that the target lesions were treated by study device (ranger dcb 6 mm x 150 mm).The target lesion #002 was in the right proximal superficial femoral artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length 100 mm with 70% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed using 5 mm x 100 mm sterling over the wire balloon pta balloon.Treatment of target lesion was performed by dilation using study device, 6 mm x 100 mm ranger drug-coated balloon.Following treatment, the final residual stenosis was noted to be 29%.During treatment of target lesion #002, complication of dissection of grade c was noted due to 6 mm x 100 mm ranger drug coated balloon.In response to the complication, balloon dilation was performed using 6 mm x 100 mm ranger drug coated balloon.Following treatment, the final residual stenosis was noted to be 29% and the complication of dissection was considered resolved.On (b)(6) 2023, the subject was discharged from the hospital on clopidogrel.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20412230
• Report Number: 2124215-2024-59717
• Device Sequence Number: 8303930
• Product Code: ONU
• UDI-Device Identifier: 08714729976189
• UDI-Public: 08714729976189
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 10/09/2024

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: 01/31/2025
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 01003H23
• 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: 09/16/2024
• Initial Report FDA Received Date: 10/09/2024
• Date Device Manufactured: 02/01/2023
• 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 Sex: Female
• Patient Race: Black Or African American